Welcome to KBC

Serving Medical Device Companies Worldwide

In order to sell a medical device, a company must meet the regulatory requirements of each market where that medical device is to be sold. The purpose of these requirements is to demonstrate that products are safe and effective prior to sale. However, many medical device companies lack sufficient experience or the personnel needed for FDA or other regulatory or standards compliance.

Ken Block Consulting offers services at reasonable rates to assist companies in ensuring the production of safe and effective medical devices for US and international markets. Our consulting services cover all areas of FDA regulation that govern those involved in the production and distribution of medical devices.

 

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SERVICES

Ken Block Consulting specializes in regulatory affairs related to medical devices and medical device companies (this does not include pharmaceuticals). “Regulatory Affairs” encompass the activities required to ensure the legal compliance of medical device companies, so that their devices can be legally marketed and sold.

 

REGULATORY REQUIREMENTS:

Successful medical device companies have a comprehensive understanding of FDA regulatory requirements: specific documentation, record keeping, submissions, and assignments. Ken Block Consulting has a high level of expertise in FDA regulatory compliance knowledge and implementation. We also have direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.

 

REGULATORY SERVICES PROVIDED:

Ken Block Consulting offers a variety of services to address the needs of medical device inventors and companies, both those that are new to FDA regulations and those that have established regulatory affairs departments in need of additional assistance.

Listed below are examples of services provided. Please visit our Services pages for more in-depth information. If a specific service you are seeking is not listed, please contact us directly at info@kenblockconsulting.com or through the form under the Contact section of this site. We would love to help!

 

Regulatory Compliance

•   FDA Regulatory Compliance Strategy

•   FDA Liaison (Compliance/Small Business/Field Office/etc.)

•   Establishment Registrations (Initial/New/Modified/Annual)

•   Device Classifications and Product Listings

•   Assignment of FDA Official Correspondent for Foreign Medical Device Companies

•   International Import/Export Issues

•   Certificates to Foreign Government

•   On-Site FDA Visits and Investigations

•   US Agent for Foreign Medical Device Companies

•   QMS Gap Audits and Mock FDA Inspections

•   Comprehensive, On-Site Training

 

Regulatory Strategy and Submissions

•   Premarketing Clearance 510(k) Submissions

•   Product Pre-Submission Conferences / Meetings

•   Device Classifications

•   510(k) Exemptions and Special Controls Requirements

•   FDA Biocompatibility Requirements

•   EU Technical Files

•   FDA Initial Product Reports (Laser Devices)

•   Laser Testing and Classification (FDA + IEC 60825-1 + AS/NZ 2211)

 

Interaction with FDA

•   On-Site FDA Visits and Investigations

•   FDA Inspection Observation (Form 483) Responses and Activities

•   FDA Warning Letter Responses and Activities

•   FDA Industry Meetings and Other Public Meetings

 

Marketing and Labeling

•   CE Marking

•   Labeling Specification and Review

•   Marketing Materials Review (Websites, Inserts, Press Releases, etc.)

 

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REGULATORY STRATEGY

Regulatory strategy encompasses a broad range of activities, some related to regulatory requirements, some related to good business practices, and some involving both. Regulatory Strategy can be subdivided into the following stages: preliminary activities, pre-market, product launch, preparation, and post-market. Services that KBC has provided in each stage are highlighted below.

 

Preliminary Activities

•   Regulatory Research

•   Allowable Medical Claims

•   Applicable FDA Regulations

•   Quality System Review

•   QMS Gap Audits

•   Development of FDA Strategy

•   Development of Business Regulatory Strategy

•   Investor Liaison and Communications

 

Pre-Market

•   Trade Show Strategy and Labeling

•   Investigational Device Exemptions (IDE)

 

Preparation

•   Packaging and Materials

•   Testing and Validations

•   510(k) Submission

•   Quality System Creation / Improvement

•   Training and Mentoring of Staff

 

Product Launch

•   510(k) Clearance

•   FDA Establishment Registration

•   Device Listing

•   Label and Import Issues

 

Post-Market

•   FDA Inspections

•   Device and Label Changes

•   Service and Repair

•   Recalls and Upgrades

•   Resolve FDA Problems

 

QUALITY SYSTEMS

 

QUALITY SYSTEMS REQUIREMENTS:

Comprehensive quality management systems in compliance with QSR regulations are required for all US companies involved with medical device design, manufacture, assembly, contract sterilization, installation, relabeling, remanufacturing, repacking, specification development, and initial distribution.

Separately, the International Organization for Standardization (ISO) has a quality management system standard for medical device companies, which is optional for U.S. medical device companies that only sell domestically but is often a requirement for medical devices distributed internationally, including within Canada, Europe, and Australia. Compliance to ISO standards must be accomplished before placing the CE mark on a medical device.

 

Examples of Services Provided

•   Quality System Gap Analysis/Audit

•   Establishing/Evaluating QSR/ISO Compliant Quality Systems

•   Modifying Quality System to Include FDA/ISO Requirements

•   Authoring Quality Manuals, Policies and Procedures

•   Developing Work Instructions and Process Flow Diagrams

•   Establishing Medical Device Reporting Procedures

•   Ensuring Appropriate Design, Change and Document Controls

•   Device Master Records and Device History Records

•   Design History Files

•   Complaint Handling and Investigations

•   Corrective and Preventive Action (CAPA) Procedures

•   Paper-Based and Software-Driven Quality Systems

•   Quality Objectives and Management Reviews

•   Quality System Training

•   U.S. and International Quality Audits (Suppliers/Sterilizers/Manufacturers

 

FDA SUBMISSIONS

In order to legally market a new or modified medical device in the US, the most common forms of market authorization submissions to FDA are the 510(k) premarket notification submission and the PMA premarket approval. Another lesser-known premarket submission is the De Novo petition; however, with more novel technologies and new intended uses coming to the device industry, the De Novo pathway is becoming more common. Each of these submission types result in a determination by FDA that clears [510(k)], approves [PMA], or grants [De Novo] marketing rights to the successful submitter.

Other submissions to FDA include Pre-Submissions (Pre-Subs), Breakthrough Device Designation Request Q-Submissions, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), and Master Files, to name a few. Please contact Ken Block Consulting (KBC) to discuss these FDA submissions and how our team can help you achieve US market introduction for your medical devices.

 

BREAKTHROUGH DEVICE DESIGNATION REQUESTS

One special type of Q-Submission is the Breakthrough Device Designation (BDD) Request, intended for those devices addressing a life-threatening or seriously debilitating disease or condition. The KBC team has helped multiple clients achieve Breakthrough Device status for innovative and important new device technologies, including software as a medical device (SaMD). Read about KBC successful BDD submissions for our clients, as well as links to published articles authored by KBC on the Breakthrough Device Program, here.

 

REGISTRATION & LISTING / US AGENT

All establishments or facilities involved in the design, production or distribution of medical devices intended for use in the United States are required to register annually with the FDA. Additionally, all medical devices marketed in the US must be listed with FDA in association with a registered establishment.

Any foreign establishment must identify a single United States agent (US Agent) for that establishment. KBC can assist with additional activities outside of the US Agent responsibilities, including reporting of adverse events under MDR regulation and submitting 510(k) Premarket Notifications.

A foreign company may choose to have the US Agent also act as the Official Correspondent. The official correspondent is the person designated by the company to be the initial point of contact between FDA and the company.

 

AUDITS & INSPECTIONS

 

AUDIT & INSPECTION SERVICES

Companies engaged in medical device activities are required to establish appropriate procedures for mandatory internal QMS/quality audits to check the ongoing compliance of each medical device company facility. If a company fails to conduct an appropriate internal audit according to the company procedure and established audit schedule, they run the risk of operating out of compliance with applicable regulations and/or standards. Unfortunately, any such resulting undesirable non-compliant situation could be discovered during an FDA inspection, MDSAP/ISO audit, M&A due diligence audit, or other such activity.

However, internal company staff are often the least objective auditors when comparing their own company operations to the applicable regulatory requirements. To avoid any costly remediation activities to correct non-compliance situations, medical device companies should consider using the best QMS consultant available to discover any compliance problems as early as possible. Ken Block Consulting frequently conducts internal QMS/quality audits, supplier audits and independent regulatory compliance gap analysis audits (FDA, MDSAP, ISO, etc.) at all types of medical device companies (specification developers/designers, sterilization facilities, manufacturers, contract manufacturers/suppliers). In addition, our unique risk-based audit reporting approach provides our clients with actionable priorities in addressing any discovered problems. Ken Block Consulting offers on-site/in-person audit services as well as remote/virtual audit services to meet every client situation.

Inappropriately addressed compliance problems can quickly become serious and expensive. In one such past example, Ken Block Consulting was approached by a large multinational medical device manufacturer six months after they had received a Warning Letter from FDA regarding two of their four company facilities. Despite prior assistance from two of our competitors over six months, their compliance situation had not been resolved - FDA remained unhappy with QMS progress and the manufacturer was subject to an active Department of Justice investigation regarding their company activities. Ken Block Consulting conducted an independent FDA compliance gap analysis of all four company facilities (one design, three manufacturing), where dozens of yet unidentified critical-risk and major-risk QMS deficiencies were discovered. We then replaced our competitors, created and implemented the comprehensive remediation plan on-site at all four facilities, and successfully addressed the systemic QMS problems to resolve this serious compliance situation.

In addition to conducting pre-audit and pre-inspection examinations of client operations, Ken Block Consulting expertly prepares and trains companies of all sizes - from startups to multinational corporations - regarding the practical handling of FDA inspections, MDSAP and ISO audits, M&A due diligence audits and other similar activities. We also efficiently and effectively manage the eventual inspection or audit activities, as well as successfully lead the necessary efforts in successfully resolving any identified compliance problems such as FDA Form 483 Observations, FDA Warning Letters, ISO/CE Notified Body and MDSAP non-conformances (NCs), etc. With offices in the US, Europe and Asia, our global team tackles audit and inspection activities worldwide.

 

Examples of Services Provided

•   FDA 21 CFR Part 820 Compliance Gap Analysis Audit

     -   Audit of Quality Documents and Records

     -   Interviews with Key Quality Personnel

     -   On-Site Tour for Visual Assessment

     -   Corrective Action Suggestions Using Your CAPA Process

•   Mock FDA Inspection

•   FDA Inspection Support

     -   On-Site Support While FDA Inspection Is Conducted

     -   Post-FDA Inspection Support if Voluntary Actions Are Required

•   ISO 13485:2016 Compliance Gap Analysis Audit

•   MDD/MDR Compliance Gap Analysis Audit

•   MDSAP Compliance Gap Analysis Audit (Medical Device Single Audit Program)

•   Internal Quality Audit

•   Supplier Evaluation Audit

•   e-Audit

 

VALIDATION

 

VALIDATION REQUIREMENTS:

Validation is the process of establishing objective evidence that a process or product consistently meets the requirements defined for it, thereby demonstrating its safety and effectiveness. In addition to the validation of finished medical devices, the FDA also requires validation of software used as part of a production or quality system, and processes that cannot be fully verified by subsequent inspection and testing.

 

MEETING THE REQUIREMENTS:

The consultants at Ken Block Consulting have deep experience and expertise in creating and reviewing validation master plans, validation protocols, and other related documents for a wide range of medical device manufacturers. Using a risk-based approach, KBC’s consultants work closely with clients. Since understanding of the regulations is an essential part of compliance, KBC also offers validation-related training, which is tailored to each client’s needs for anything from classroom seminars to one-on-one workshops and/or guidance.

 

Tailored Validation Services Provided

•   Validation Master Plans, SOPs, and Protocols

•   Retrospective, Concurrent, and Prospective Approaches

 

Equipment

•   Calibration

•   Adjustments

•   Maintenance

 

Environment and Storage

•   Effects on the Product

 

Validation

•   Manufacturing Processes and Software

•   Quality System Software

•   Design and Final Product

•   Packaging and Shipping

•   Revalidation

 

Testing

•   Sterility Assurance

•   Aging and Durability

 

COMPLIANCE & REMEDIATION

 

COMPLIANCE

Medical devices are highly regulated products. Many country-specific and region-specific regulations have been established, which outline the requirements for the legal design, manufacturing, import, promotional marketing and distribution/monitoring of medical devices within that country or region. Many of these regulations leverage other legal requirements to which compliance is also required, such as international standards, guidance documents, announcements to industry and other related laws and regulations. Before and after entering each market, medical device companies must comply with these many rules and regulations, depending on the specific market, technology, risk and intended use of the company’s medical device products. As global regulatory experts, Ken Block Consulting helps companies identify, understand and comply with all applicable regulatory requirements that apply to any device for any given market.

It is not always enough to understand the words in an FDA regulation, but also the "spirit” or “intent” of the regulation - making compliance challenging for companies new to the US medical device market. In addition, FDA periodically checks company compliance through on-site FDA inspections of company facilities worldwide, as well as using other direct and indirect compliance techniques (direct company inquiries, import checks, etc.).

Lack of compliance with these many rules and regulations can lead to FDA enforcement actions (Warning Letter, Import Alert, etc.), product recalls, regulatory remediation or other time-consuming and costly actions. Because of the notoriously tough FDA regulations and compliance enforcement, the United States is considered to be the most tightly regulated and vigorously enforced market - but also the largest and most lucrative. The best FDA consultants have experience in the wide variety of compliance activities needed to help medical device manufacturers handle any possible FDA regulatory situation. Ken Block Consulting specializes in ensuring company and product compliance to all FDA regulatory requirements, determining the best FDA compliance pathway for unique company or product situations, preparing for and managing FDA inspections, avoiding future FDA compliance problems through auditing and consulting assistance, and resolving compliance issues that have already been identified by FDA.

 

REMEDIATION

When a company discovers that any of its practices, documents or records are out of compliance with any global regulations, a remediation plan may be necessary. Remediation activities usually include CAPA investigation to identify the root cause of regulatory non-compliance within the company’s quality system and implementation of a plan to address systemic gaps - ultimately bringing the medical device company into regulatory compliance. Because remediation can become a complex and time-consuming process, it is important to hire the best regulatory consultants who are successful at identifying, addressing and resolving such situations effectively and efficiently. Ken Block Consulting works collaboratively with companies to detect underlying compliance disparities, remediate the regulatory gaps, and apply corrective measures to ensure future compliance and successful standing both with the applicable regulatory authorities and within the medical device industry.

 

Recall

 

DHF Remediation

•   Gap Analysis of Device Documentation

•   Adherence to FDA Design Control Regulations

•   Create and/or Update Device Plans and Procedures

 

Warning Letter and 483 Resolution

•   Communication with FDA

•   Creation and Implementation of Remediation Plans

 

Quality System

•   Quality System Establishment, Implementation, Maintenance

•   Quality System Audits - FDA, MDSAP, ISO 13485:2016

•   Quality System Improvement Plans

•   Document and Change Control

 

CAPA

•   CAPA Management

•   CAPA Investigations, Root Cause Analysis

•   CAPA Action Plans and Implementation

•   CAPA Effectiveness Checks

•   Non-Conformance Management

 

MDR

•   Complaint Evaluation and Investigation

•   Communication with and Reporting to FDA

•   Input into the CAPA Subsystem

 

RISK MANAGEMENT

Risk management is more than risk analysis; it is the systematic application of policies, procedures, and practices to the analysis, evaluation, and control of risks. It is a central requirement of the implementation of design controls in the Quality System Regulation (QSR).

Regulatory agencies expect medical device companies to use a risk-based approach for various activities related to both products and processes. This includes ranking the impact of different corrective action and preventive action (CAPA) activities, prioritizing validation master plan activities, and so forth. ISO 14971 is the standard typically referenced for application of risk management and the risk-based approach.

 

ISO 14971 Training

 

Risk-Based Ranking of Activities Related to QMS

 

Creation of Risk Management File Contents

•   Risk Management Plans

•   Identification of Hazards

•   Risk Analysis, Evaluation, Control, Mitigation

•   Overall Residual Risk and Evaluation

•   Risk / Benefit Analysis

•   Risk Management Report

 

TRAINING

Implementing organization-wide change is no easy task. Educating personnel, from company management to line operators, is a vital step in successfully bringing positive change to any organization. The consultants of Ken Block Consulting have assisted clients of all sizes throughout the world in addressing issues in all areas of quality management and regulatory compliance. We offer training and seminars in conjunction with larger projects or as educational activities to keep your company up to date in regulatory and quality matters. Whether you are a small start-up trying to navigate the often complex regulatory pathways to market, or a multinational corporation hoping to refine your quality system or diversify your product range, Ken Block Consulting has the specialists and the know-how to address your company’s unique needs.

 

Examples of Training Topics Offered

•   Analysis of Data

•   Basic 510(k) Seminar

•   Complaint Handling

•   Corrective and Preventive Action (CAPA)

•   Deciding When to Submit a 510(k) Application to FDA

•   Document and Change Control

•   FDA 21 CFR 820

•   FDA “Hot Topics”

•   FDA Inspections: Preparation, Management, and Response

•   FDA Submissions

•   FDA Update

•   Gathering Clinical Data in US Using Unapproved Devices

•   Good Documentation Practices (GDP)

•   How to Market Medical Device Products in the US

•   Internal Auditing

•   Investigational Device Exemption (IDE)

•   ISO 13485 and ISO 9001

•   Management Review

•   Medical Device Reporting (MDR)

•   New FDA Rules

•   Non-Conforming (NC) Handling

•   Official Correspondent Duties and Responsibilities

•   Process Monitoring

•   Process Validation (Basic and Advanced)

•   Quality Agreement

•   Quality System Regulation (Introduction and Advanced)

•   Record Control

•   Risk Information Submitted to FDA in 510(k) Applications

•   Risk Management

•   Sampling Strategies

•   Software Topics (IEC 62304 and FDA)

•   Software Validation (Basic and Advanced)

•   Sterilization

•   Supplier Partnership / Controls

•   US Agent Duties and Responsibilities

 

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BREAKTHROUGH DEVICE DESIGNATIONS

 

BREAKTHROUGH DEVICES

Ken Block Consulting (KBC) has achieved the impressive Breakthrough Device Designation (BDD) status for four (4) different novel and impactful medical devices. Our team would be happy to discuss your company's innovative new technology, whether your proposed device could be positioned appropriately for a Breakthrough Device Designation Request to the FDA, and how KBC can create the most appropriate BDD Q-Submission.

As background, FDA established the Breakthrough Devices Program to help fast-track the US market introduction of highly innovative medical device technologies still under development, which hold the promise to address life-threatening or permanently debilitating diseases and conditions. Candidate devices may be diagnostic-oriented or treatment-oriented, but companies must formally apply to the FDA and can only gain BDD status by meeting specific criteria. BDD advantages include close collaboration with an assigned FDA review group, agreement with FDA on the device validation data needed to enter the US market, frequent meetings with their FDA team, and prioritized FDA review of the eventual market authorization application: De Novo, “Breakthrough 510(k)” or PMA.

 

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ABOUT KBC

 

COMPANY HISTORY

In 2005, Ken Block Consulting (KBC) began as the one-person venture of Kenneth L. Block, whose background includes an undergraduate science degree in physics and more than 35 years of experience in FDA-regulated medical device and laser product technologies. Mr. Block worked within manufacturing, validation, quality and regulatory areas for several Class II medical device companies (including senior management positions) before starting his consulting company. He has also earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).

In 2009, an office in Tokyo was added as a hub for clients throughout Asia, along with the formation of Ken Block Consulting LLP in Japan (subsequently incorporated as Ken Block Consulting Co., Ltd. in 2017). In 2018, Ken Block Consulting France SAS was formed as a regional hub for clients throughout Europe, with an office established in Paris. The US location of KBC serves as the central hub for consulting projects performed worldwide, coordinated among our three global locations.

Over the years, Mr. Block and other KBC employees have authored original informative content that has been presented in published articles throughout the global medical device industry, given dozens of invited speeches at medtech events worldwide, and participated in conference panel sessions covering a wide variety of regulatory topics. KBC work has even been referenced by others as both law school citations and industry article references. These many accomplishments have contributed to our international reputation as industry experts.

 

OUR APPROACH

Ken Block Consulting is dedicated to providing the highest quality regulatory, validation, quality system and related consulting services to medical device companies worldwide. The experienced KBC team is committed to contributing value, establishing trust, showing respect, and delivering success to our clients. With this approach, our higher goal is to empower clients with the knowledge and ability to perform more effectively in the future.

KBC will always protect client confidentiality and provide honest and accurate answers. We follow a policy of ethics and transparency with our clients so that they, in turn, can approach regulatory authorities with the information and confidence necessary to succeed. Many clients have provided testimonials to the excellent work and successes achieved by KBC, both for regulatory projects (including FDA submissions) and quality system projects (including FDA inspections).

 

VALUES

KBC is known for tackling unique challenges and complex projects with intelligence, creativity and flexibility for clients ranging from small startups to large multinationals. These core principles, along with our experience and approach, are the basis for the KBC vision, mission, and values.

 

VISION, MISSION, & VALUES

 

VISION

Improving global healthcare by increasing the availability of safe, effective, and innovative medical devices worldwide.

 

MISSION

To achieve our stated vision, the dedicated mission of Ken Block Consulting (KBC) is to work closely with clients to help ensure that their regulated activities meet all applicable global compliance requirements.

The scope of our mission spans the entire lifecycle of client products, from pre-market activities such as regulatory strategy and submissions through post-market activities including compliance audits and complaint management. In pursuit of this mission, our consulting services cover initial product concept and prototyping to final device manufacturing and distribution – including design and development, verification and validation, and myriad other quality management activities needed to produce state-of-the-art devices. For each new KBC client, this mission is accomplished by applying our extensive hands-on experience from hundreds of prior medical device projects, conducted for companies from small startups to Fortune 500 multinationals. Mission success results in safe and effective medical devices, which are made available through effective quality system operations and reliable new product introductions.

 

VALUES

Our company values represent the core principles by which we operate and execute our mission:

•   Provide employees with unparalleled opportunities for career acceleration and recognition

•   Tackle projects worldwide that are unique, interesting and challenging

•   Enrich our company culture and client services through diverse employee educational accomplishments, professional certifications, work experiences, personal backgrounds, global cultures and languages

•   Apply intelligence, creativity and flexibility in the pursuit of successful client solutions

•   Foster honesty, trust and mutual respect in every client partnership

•   Embrace the highest ethical approaches to the completion of client projects

•   Contribute to increasing client knowledge, capabilities and growth

 

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REPUTATION

Ken Block Consulting (KBC) has earned our excellent reputation primarily through tackling challenging product-related regulatory submissions and resolving tough company-related regulatory compliance situations. Many new KBC clients have seen those previous successful outcomes for others, and then reached out to us for assistance.

With a goal of helping even more companies learn from our hands-on experience and successful approaches, KBC has also authored a wide variety of published articles on medical device industry topics, given invited speeches at dozens of industry events around the world, and participated in many educational conference panel sessions. In addition, KBC has been referenced or quoted in articles written by others, plus our work has been cited by prestigious universities and law schools. These additional activities and recognitions have helped establish our international reputation as thought leaders within the medical device industry.

In the end, what counts most is the achievement of excellent results for our clients – so we are always excited to apply our capabilities and knowledge to the next project, and always looking forward to meeting new client companies!

 

PUBLISHED ARTICLES

For many years, numerous professional organizations and publications within the medical device industry (both print and online) have reached out to Ken Block Consulting (KBC), requesting interesting content for their target audiences. In response, we have authored over 20 original articles across a broad spectrum of topics, from software validation and FDA submissions to usability and regulatory due diligence. Readers are typically regulatory and quality professionals, medtech executives, engineers and others. Internationally recognized for our regulatory and quality expertise (and consistent with our office locations in the US, Asia and Europe), original KBC industry articles have been published around the globe in the English, Japanese and French languages. Unlike "pay to play" publications (where articles by other consultants may appear), KBC content has always been invited by the relevant editorial management, with compensation never paid by KBC or received by KBC. Some of these invited articles can be located here, including any links to any content available online.

 

INVITED SPEECHES

Over the past 15 years, Ken Block Consulting (KBC) has been invited by medical device industry groups, quality and regulatory associations, educational conference organizers and startup accelerators to author and present speeches at events across the globe. Our hosts have included Regulatory Affairs Professionals Society (RAPS) Japan, American Society for Quality (ASQ), American Medical Devices and Diagnostic Manufacturer's Association (AMDD), Japanese Imaging and Radiological Association (JIRA), and many others including medical device trade shows in the UK, Japan, Ireland, France, Germany, etc. To date, we have given over 50 such speeches, each containing unique content focused on the industry professionals attending these international events, from executives and engineers to regulatory and quality professionals. The broad range of speech topics matches the deep KBC hands-on experience in these areas including cybersecurity, 3D device printing, investigational device studies, newly released FDA guidance documents, software validation, FDA inspections, market entry strategy, and more. More information on past speeches can be located here.

 

PANEL SESSIONS

As recognized knowledge leaders with many proven client successes, Ken Block Consulting (KBC) has been invited to participate in numerous industry conference panel sessions in the US and Europe, covering topics from wireless device connectivity and 3D printing to US market entry and FDA regulatory strategy. These events include direct interaction with other panelists and audience members, allowing KBC to leverage our deep experience to help others who are seeking guidance. Co-panelists often include a mix of successful medtech entrepreneurs, regulatory attorneys, FDA employees, subject matter expert (SME) engineers, and others such as medical device reimbursement specialists. More information on past panel sessions can be located here.

 

LAW SCHOOL CITATIONS

Law school journals published by Southern Methodist University (Dedman School of Law), the University of Michigan and the University of California (Davis) have all included papers referencing work that was created by Ken Block Consulting (KBC), such as website content or published articles. KBC authored content has also been used as part of Harvard University coursework on cybersecurity, plus referenced in publications by other educational organizations. Given our strong capabilities and knowledge in the regulated medical device industry, KBC serves as an expert source of content for academic writers on topics including digital health, FDA regulatory pathways, usability and FDA regulations for mobile apps. Some of these citations can be located here, including any links to any content available online.

 

ARTICLE REFERENCES

Given our reputation for both deep knowledge and excellent results within the global medical device industry, Ken Block Consulting (KBC) is periodically recognized in articles written by other authors. As a result, several published articles written by others have either referenced KBC or included quotes from KBC. These articles are either seeking our viewpoint regarding some focused regulatory topic where KBC has deep experience and knowledge or are covering successful client KBC work involving unique medical device technology. Some of these article references can be located here, including any links to any content available online.

 

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what's new

  • BREAKTHROUGH DEVICE #4 - COMBINATION CANCER TREATMENT

    Ken Block Consulting most recently helped an organization achieve Breakthrough Device Designation for an innovative cancer treatment device. This is KBC's fourth client medical device, and our first combination device, to have achieved Breakthrough Device status. Our client is applying proprietary and novel technology to address life-threatening cancerous situations for populations who currently have no alternative treatments.

     

    Please contact us (info@kenblockconsulting.com) to discuss your company's new and impactful medical device technologies, and how Ken Block Consulting can help you achieve FDA regulatory success!

  • JACRI FDA SPEECHES

    Ken Block was invited to give two speeches to Japan Association of Clinical Reagents Industries (JACRI) members in Tokyo on November 28. He discussed FDA topics including new 510(k) guidance documents and new QMSR. The event had over 100 attendees! This presentation marked almost exactly 14 years since his first JACRI speech as their invited FDA expert.

  • FDA HQ VISIT

    Ken Block is fresh off a successful meeting with the FDA at their headquarters, with a client from Japan. Visit our Services pages to learn more about what KBC can do for you!

  • BREAKTHROUGH DEVICE INTERVIEW

    Ken Block recently gave an interview with Medtech Insight regarding the FDA's Breakthrough Device Program.

featured services

  • COMPLIANCE

    As technology evolves, regulations evolve. We help your business find its way in a tumultuous environment.

  • US MARKET ENTRY

    Whether your firm is large or small, new or established, we will guide you into the largest medical device market in the world. 

  • FDA INSPECTIONS

    FDA inspections have fully resumed. We will get you prepared via on-site and remote support.

  • BREAKTHROUGH DEVICES PROGRAM

    If you have a novel technology that addresses a life-threatening or seriously debilitating disease or condition, we can help you navigate the potential for Breakthrough Device Designation, which fast-tracks the US market introduction along with other advantages.

  • SAFER TECHNOLOGIES PROGRAM (STeP)

    If you have a medical device that significantly improves the safety of currently available treatments or diagnostics for a less serious disease or condition, we can help you navigate STeP in order to get your product to the US market faster, among other advantages.

testimonials

  • FDA SUBMISSION PROJECTS

    “This is an incredible achievement [510(k) submission] that only came about due to hard work and a commitment to make this a reality. It is a significant milestone that will provide a lasting impact on our ongoing capabilities. Thank you so much for your collaborative efforts on our behalf.” – CEO

     

    “I'm really happy with the long-awaited 510(k) clearance. We couldn't have made it this far without your help. Thank you very much for your cooperation over the long term.” – Project Manager

     

    “I would like to give the highest recommendation for the outstanding job Ken Block Consulting has performed and continues to perform for my company. Mr. Block and his consultants outlined a unique and successful strategy for us to obtain 510(k) clearance for our first-generation device. He then created a strategy of serial iterations of the device to get it to the point of market readiness. This strategy has been reviewed and approved by our primary funding agency, as well as the FDA.” – Founder & CEO

     

    “Thank you, Ken, for all you have done. I know you were key to our success in this [510(k) submission] and we appreciate all your support and hard work to get us here!” – President

     

    "The team at KBC organized a superstar application for Breakthrough Device Designation. The application was organized, persuasive and comprehensive. We approached the FDA with confidence that our device met the requirements of the Breakthrough program." – President

     

    “As a Swiss Medtech SME [small / midsize enterprise], we are working with KBC to support our RA team for the US FDA related topics. So far, we succeeded with three 510(k)s and one FDA inspection. If we have to describe them with three words, we would use: professional, reactive and listening.” – CEO

     

    “Little shots can become big shots when they use Ken Block Consulting!” – President

     

    “Our company is very happy to have obtained the clearance this early for Traditional 510(k), and we really appreciate your big effort.”  – Global RA/QS Manager

     

    “We recently finished an FDA pre-submission meeting. Ken Block did a fabulous job of presenting our case. Everyone in the room was extremely impressed. All of the comments that returned from that meeting were positive. Some members stated they had never seen a better presentation. It made me proud to have engaged Ken Block and his team to get us the proper strategy and to be able to present our case.” – Founder & CEO

     

    “Thank you for your effort for the Substantial Equivalence. I see that an additional SE Letter is being issued, too. We are truly thankful for the KBC work.” – Project Manager

     

    “Ken successfully strategized, orchestrated and executed not just one but two medical device FDA clearances for our company. Throughout the entire process he coordinated every resource necessary from his team and mine by facilitating everyone’s talent into one collective voice.” – President

     

    "We are happy with the guidance that the KBC team has provided for our engagement with FDA. We feel much more confident in our strategy and options now.” – Quality, Regulatory, and Clinical Trials Manager

     

    "You and your team were pivotal in our company's success as we transitioned from a Class I (MDDS) to a Class II (510(k)) medical device. With your guidance in place, we were able to remain in compliance while rapidly growing our business, all the way through to the acquisition of our company." – CEO/Founder

     

    “Of note, one never completes a journey without staying the course. Thanks for supporting us to the finish line [510(k) submission].” – CEO

  • QUALITY SYSTEM PROJECTS

    “In our firm’s 25+ year history, KBC is one of the most experienced, down-to-earth, and no-nonsense groups around.  Most recently, KBC has helped our client further refine and implement a compliant and manageable quality system that they are comfortable with.  We highly recommend KBC.” – Partner

     

    “We appreciate all of you and the KBC team's support for our FDA inspection. Without your help, we could not have coped with this matter.” – Vice President

     

    "Ken came into a developing situation and was able to quickly and accurately assess our quality, regulatory and compliance landscape. He then dove in and handled FDA communications, a recall, supplier audits and CAPAs. This allowed us to move forward in important areas while filling full-time positions." – Member, Board of Directors

     

    “I would like to thank you and your employees for the excellent support before and during the FDA inspections last week. As you have probably been informed, both inspections passed without any 483 observation.” – Global QA/RA Director

     

    “I give the highest recommendation to Ken Block and his team. I find them to be of the highest quality in ethical standards. They are a ready and complete resource for the regulatory needs of our startup company for becoming a real medical device company. We have built our quality system based upon the recommendations and continuing education that has ensued.” – Surgeon & Founder

     

    “I am glad to know very, very good news from you [issuance of FDA inspection close-out letter]. Again, thank you for your strong support always.” – General Manager

     

    “Many, many thanks to you and everyone on your team for the FDA inspection this time. Thanks to all the KBC efforts, we could go through this inspection without any major problem. I really appreciate you and your team from the bottom of my heart.” – President & CEO

     

    “We really appreciate your and your team's kind support for MDSAP audit. The audit by TUV-Rheinland was finished with no nonconformance. Once again, thank you very much for your kind support and I kindly ask you for your ongoing support.” – Corporate Vice President

     

    “I have seen Ken busy as the dedicated business owner of Ken Block Consulting (KBC) while developing quality control measures for testing our prototypes, implementing standard operating procedures for our quality manual, and working long hours with a “whatever it takes attitude.” He is at the forefront of understanding FDA and ISO guidance/regulations, and I would highly recommend Ken to assist with any consulting in this arena.” – President

     

    “Thank you very much for your help with the gap audits, procedures, record reviews, and pre-inspection/during-inspection assistance, guidance and interpreting, and supplementing the FDA inspector in accurate English. The very good results of this inspection are largely due to your company's efforts.” – Quality Manager

     

    “The seminar was more active than expected, and the audience eagerly listened to your lecture. This was a beneficial experience to learn the 510(k) process based on the actual situation.” – R&D Manager

     

    “We had engaged KBC to assist us in the preparation for the FDA inspection. The support given by the KBC team has been very useful. They have helped us to refine our procedure and process, conduct competent training, which effectively puts us in a better situation during the FDA inspection. We are very grateful for the support from the KBC team.”  – QA Manager