Mock audit: The big trial run for medical device manufacturers

Orchestras have their dress rehearsals, athletes complete trial runs, and in the medical device industry there are the preparations for the "big performances". Before an audit with the corresponding costs is due, a so-called mock audit is recommended.

A mock audit is often carried out according to the criteria of a certification body, such as DIN EN ISO 13485. The essential difference is a "real” audit involves considerable costs and the subsequently needed certifications are vital to companies, whereas the mock audit is a thorough and conscientious examination to gather information upfront and enable you to clarify issues detected if there.

Especially when the certification according to MDR or IVDR regulations is pending and a visit by the Notified Body is in prospect a mock audit is a good idea. By thoroughly auditing the company for conformity with the applicable standards, the ability to act is enabled and a continued certification for your medical devices may be ensured.

The upcoming audit by a Notified Body often causes tension at medical device manufacturers. This is understandable as in addition to numerous regulations from MDR, DIN EN ISO 13485 and MPDG the processes in your company are extremely complex and involve many interlocking activities. To avoid unpleasant surprises a test run in form of a mock audit therefore is extremely reliable.

Our expert external auditors at NEMIUS are happy to conduct a mock audit for various medical device manufacturer certifications. With a critical eye, attention to detail and a neutral outside perspective, we can take a close look at your company. This way, you can remain calm when the Notified Body appears at your premises for the audit.