Compliance and Remediation

Compliance

 

Across the globe, governments treat medical devices as highly regulated products because of their direct impact on patient safety and health. Many country-specific and region-specific regulations have therefore 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.

 

For example, companies that promote, design, manufacture, sterilize, import and/or distribute medical devices intended for the United States market must comply with all relevant FDA regulations, associated FDA rules, FDA guidance documents, etc. However, 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. This discovery may happen during an internal audit, an external Notified Body (ISO/CE) or Auditing Organization (MDSAP) audit, an FDA inspection or an external compliance gap analysis audit conducted by an independent regulatory consultancy like Ken Block Consulting. 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

483 Resolution   +

  • Communication with FDA
  • Creation of Remediation Plans
  • Implementation of Remediation Plans

Warning Letter   +

  • Communication with FDA
  • Creation of Remediation Plans
  • Implementation of Remediation Plans

Quality System   +

  • Quality System Establishment
  • Quality System Implementation
  • Quality System Maintenance
  • Quality System Audits - FDA, MDSAP, ISO 13485:2016
  • Quality System Improvement Plans
  • Document Control
  • Change Control

CAPA   +

  • CAPA Management
  • CAPA Investigations, Root Cause Analysis
  • CAPA Action Plans
  • CAPA Implementation
  • CAPA Effectiveness Chacks
  • Non-Confomrance Management

MDR   +

  • Complaint Evaluation
  • Complaint Investigation
  • Communication with FDA
  • Reporting to FDA
  • Input into the CAPA Subsystem