Let’s face it – no one likes being told what to do, and device manufacturers are no exception. But FDA approval of your medical devices is an absolute MUST if you want to succeed in the marketplace – and that means listening to everything the agency tells you to do.
And they WILL tell you what to do on a regular basis. It’s kinda their thing, and there’s no avoiding it. 😉
Accepting this pre-arranged marriage of compliance with the FDA is not easy, but acceptance is the fifth and final stage of regulatory grief. Getting here can feel a bit like you’ve summitted Mt Everest after navigating the ups and downs of denial, anger, bargaining and depression.
Unfortunately, after completing all that pre-submission and 510(k) submission work, many manufacturers fall into the trap of thinking they can hand that newly-approved project off to production and move onto the next big revenue-generating idea.
But just because you’ve been granted FDA approval of your medical devices does not mean that you’ve finished the race. Regulatory compliance is a marathon, not a sprint, and you still have a LOT to do.
Do the words Quality Management System (QMS) ring any bells?
Every manufacturer needs a QMS, and every product needs a complete design history file, device master record and device history record (among other things). FDA auditors just LOVE finding incomplete or missing QMS files, and once they do, they can start looking at other components of your QMS.
You may not like what they find, especially if you have not done your due diligence and verified the QMS status of your contract manufacturers.
Need help moving through the stages of regulatory grief? I’m a certified regulatory grief counselor, and I can help: https://leanraqa.com/