FDA Audit Checklist For Medical Devices

Check that the medical device organization has documented and implemented procedures for controlling documents and records. Audit observations should provide evidence that these controls are effective.

Comparing observed nonconformities with data from other quality information sources will allow for the identification of issues which might pose threats to product conformity.

1. Risk Assessment
One of the key aspects of medical device compliance is being able to demonstrate your quality system can deliver safe products. This requires understanding the risks a device might present to users and then estimating and evaluating these risks before controlling and overseeing them throughout its lifespan.

This may involve conducting a risk analysis during the design phase to identify any foreseeable hazards, assessing their effects and developing mitigation strategies, as well as revisiting these risks during production to make sure your controls are effective.

The FDA requires medical device manufacturers to conduct a risk evaluation prior to any premarket inspection, whether that happens as part of the PMA approval process or subsequent to receiving 510(k) clearance.

2. Design Controls
When designing medical devices, both FDA regulations and ISO 13485 demand you keep detailed documentation – also known as your DHF (design history file) – of every detail related to design. This documentation forms a critical part of your quality system that will help with inspections.

Traceability matrixes can be extremely helpful when creating your DHF. By showing the linkages between User Needs, Design Inputs, Outputs and Verifications; as well as showing how this relationship relates to Design Validation.

When it’s time for an inspection, your DHF should be audit-ready. Prioritize documenting your process so as to make inspection easier if an unscheduled inspection arises – even though FDA usually gives months or no notice at all!

3. Production Controls
Medical devices play a significant role in people’s lives worldwide. Therefore, they must adhere to stringent industry standards to ensure safety and efficacy.

Companies must undergo audits to confirm they meet the necessary standards, with these audits conducted by various notified bodies and regulatory agencies. Their frequency depends upon your device classification.

Inspectors perform audits on facilities and equipment, employee practices, documentation processes such as CAPA, and any nonconformances are appropriately documented and addressed. We recently discussed Pre-Approval Inspections (PAIs) on our Life Science Podcast episode – click below for the full episode or check out our article here on PAIs for more details.

4. Quality Control
Medical device industries place great emphasis on quality control throughout the design and production processes, from conception to distribution. This ensures that products meet user expectations while meeting intended uses and requirements outlined. Documentation and an effective quality management system are key in reaching this goal.

At an FDA inspection, their inspectors will review your quality procedures and records as well as assess if your company complies with applicable regulations. Any violation could lead to the filing of a Form 483, an official finding which could prompt regulatory action against your business.

Your company must implement processes, employee training and tools designed to minimize 483 letters. A simple checklist may make the difference; according to surgeon and public health researcher Atul Gawande’s writings on checklists can reduce errors that cost lives.

5. Documentation
Medical devices affect many lives, and must comply with the highest industry standards. This can be ensured through auditing by regulatory bodies and international standards like ISO 13485:2016.

No matter if your company specializes in Class III absorbable sutures or IV bags filled with polyglycolic acid, an FDA inspection requires careful preparation and documentation of every step along the way. An auditor will inspect labs and equipment as well as personnel files and training records as well as manufacturing processes, quality management system records and more during an FDA inspection.

Lastly, your company must prepare itself for unannounced FDA inspections and supplier audits that could require pre-approval inspections to get approval or to submit for new indication. Pre-approval inspections verify the data included in your submission to the FDA.