How to Define a Family of Medical Devices to Streamline and Reduce Biocompatibility Testing Requirements

Medical device audits are a critical part of maintaining compliance and ensuring patient safety. For companies developing medical devices, preparing for these audits is essential to ensure that devices meet the highest standards of quality and biocompatibility. For producers in the U.S., adhering to FDA requirements, ISO 13485 standards, and Good Laboratory Practices (GLP) is necessary. Here, we’ll cover what the audit process entails, how to prepare for it, and what documentation and procedures are required to successfully navigate it.

  1. Understanding the Purpose and Scope of Medical Device Product Audits

A medical device audit evaluates the manufacturer’s compliance with regulatory standards, quality control, and the safety and efficacy of the product. Regulators like the U.S. Food and Drug Administration (FDA) and global bodies use these audits to verify that devices meet regulatory and safety requirements. Audits may vary depending on the specific phase of production, such as design, development, or post-market.

Key standards include:

  • FDA Quality System Regulation (QSR): Governs the manufacture of medical devices in the U.S.
  • ISO 13485: An international standard for quality management systems in medical devices.
  • Good Laboratory Practices (GLP): Focuses on the quality and integrity of laboratory testing for biocompatibility.
  1. Types of Medical Device Audits

There are several types of audits you may encounter:

  • Internal Audits: Conducted by the manufacturer’s quality team to ensure ongoing compliance.
  • Supplier Audits: Evaluation of third-party suppliers to confirm they meet necessary standards.
  • Regulatory Audits: External audits by regulatory bodies (e.g., FDA) to review compliance with legal standards.
  • Notified Body Audits: For companies that sell in Europe, these are part of CE marking requirements for conformity with EU Medical Device Regulations (MDR).
  1. Preparing for an Audit: What to Expect

Audit preparation begins with a solid understanding of your product’s regulatory obligations and quality requirements. Here’s a breakdown of what’s involved:

  1. Documentation Requirements

Document control is one of the most critical aspects of audit preparation. Auditors will request various documents that demonstrate your compliance with FDA, ISO, and GLP standards. Some key documents to have prepared include:

  1. Quality Manual: An overview of your Quality Management System (QMS), detailing how quality policies and procedures are documented and maintained.
  2. Standard Operating Procedures (SOPs): Comprehensive procedures for every aspect of production, testing, and quality control.
  3. Design History File (DHF): Contains all documents related to the design and development of the device, showing how it meets user needs and regulatory requirements.
  4. Device Master Record (DMR): A compilation of everything needed to produce a device, including materials, drawings, and procedures.
  5. Risk Management File: Documentation of risk analysis and mitigation for the device (typically following ISO 14971).
  6. Biocompatibility Testing Results: Test results that demonstrate device safety when in contact with human tissues, following ISO 10993 standards.
  7. Change Control Records: Records of any changes to the device design, materials, or manufacturing process and the impact assessments of these changes.
  8. Complaint and Adverse Event Reports: Data on any product complaints or adverse events that were reported and how they were addressed.
  1. Operational Preparation
  1. Internal Audits: Conduct regular internal audits to identify areas for improvement and ensure that processes align with regulations. Internal audits also prepare staff for the documentation and interview portions of regulatory audits.
  2. Employee Training Records: Keep comprehensive records of training programs for employees, particularly those involved in production and quality control. Staff should be familiar with SOPs and regulatory requirements related to their roles.
  3. Test Data Integrity: GLP-compliant data is critical for biocompatibility testing. Verify that lab notebooks, electronic records, and test results are accurate and properly signed off.
  4. Supply Chain Quality: Ensure that all suppliers meet regulatory and quality requirements. This includes documented evidence that they’ve been audited and are capable of consistently providing high-quality materials and components.
  1. Audit Day: What to Expect

On the day of the audit, the auditor will review the requested documentation and may interview employees to verify their understanding of the company’s quality practices. Here’s what typically happens:

  1. Opening Meeting: The auditor will meet with key personnel to discuss the audit’s scope, objectives, and plan.
  2. Documentation Review: The auditor will review documents related to the QMS, product design, manufacturing processes, and testing.
  3. Facility Tour: A walk-through of the manufacturing and testing areas allows the auditor to observe operational processes and hygiene practices.
  4. Interviews with Personnel: Employees may be asked about their roles, training, and understanding of quality policies.
  5. Closing Meeting: The auditor will summarize findings, discuss any potential issues, and provide initial feedback.
  1. Post-Audit: Addressing Findings and Making Improvements

After the audit, the auditor may issue a report outlining any nonconformities or areas of improvement. This post-audit phase is essential for corrective actions:

  1. CAPA (Corrective and Preventive Actions): Any issues identified must be addressed through CAPA procedures. This may involve updating SOPs, retraining staff, or improving quality control measures.
  2. Root Cause Analysis: For significant nonconformities, a root cause analysis helps identify underlying issues to prevent recurrence.
  3. Documentation Updates: Ensure all responses, actions, and revised documents are maintained as part of your QMS.
  1. Tips for Successful Audit Preparation
  • Stay Proactive: Regular internal audits and supplier evaluations help maintain compliance without the stress of last-minute preparation.
  • Maintain a Living QMS: Constantly update and improve your Quality Management System based on feedback from audits, customer complaints, and internal reviews.
  • Focus on Biocompatibility: For devices with patient contact, biocompatibility testing must meet ISO 10993 and GLP requirements. Work with a qualified testing laboratory to ensure compliance and documentation accuracy.
  • Educate Employees: Continuous training ensures that all team members understand regulatory requirements and are ready for an audit at any time.

Conclusion

Preparation for a medical device audit requires thorough documentation, robust quality systems, and regular internal reviews. With the right preparations, medical device companies can approach audits with confidence, demonstrating their commitment to quality, safety, and regulatory compliance. A well-organized and consistently updated quality system can make all the difference in achieving a successful audit outcome and ensuring patient safety.

About the Author: Prof. Łukasz Szymański

Prof. Łukasz Szymański is an expert in medical device biocompatibility testing, serving as the Chief Scientific Officer (CSO) of the ISO 17025-accredited and GLP-certified North American Biomedical Institute (NABI) and European Biomedical Institute (EBI). As a dedicated researcher and a key contributor to advancing safety standards in the biomedical field, Prof. Szymański plays an integral role in shaping scientific innovations and regulatory compliance within the industry.

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