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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.
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.)
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
BREAKTHROUGH DEVICE DESIGNATIONS
BREAKTHROUGH DEVICES
Ken Block Consulting (KBC) has achieved the impressive Breakthrough Device Designation (BDD) status for five (5) 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.
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
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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