If you have not registered with FDA as an establishment and your organization meets the requirements delineated within Part 807, then what is stopping you?
Not all auditing firms or auditors are created equal; in fact, there is “The Good, The Bad, and The Ugly” when it comes to auditors.
Why audit suppliers? We explain why some audits are necessary while most are not.
Be proactive and create just one procedure for corrective action and preventive action (CAPA). Medical device manufacturers must actually pursue PA and have documented evidence of their efforts. After all, if PA is not documented in writing, it never happened.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.
Purchasing and supplier management is one area where a supplier’s poor performance can have a direct impact on the safety and efficacy of a finished medical device. In fact, a bad supplier can easily result in a product recall.