Regulatory Auditing 

We are here to ensure you have confidence in your preparation for regulatory compliance audits

Medical Device Manufacturers are required to go through a systematic documented process by the regulatory authorities seeking to obtain evidence and evaluate if products are developed and maintained on the market in compliance with regulatory standards. This process is held periodically by Regulatory agencies which may or may not announce the audit prior to arrival at the manufacturer’s facility. Internal Audits must also be conducted by medical device manufacturers as part of the company’s ongoing regulatory obligations. Manufacturers should be aware of the increasing scrutiny by regulatory authorities, and in preparation for both internal and external audits. 

Aolete experts support manufacturers to meet this obligation by conducting mock audits to prepare for regulatory audits and equipping them with:

• Best practices to prevent audit queries and address audit findings from regulatory agencies.

• Common FDA and Notified Body audit findings in different areas of quality systems and how to address them.