When the subject of Medical Device Standards comes up, what immediately comes to mind? For most US companies, the answer would be 21 CFR 820, and ISO 13485:2016. Those who market products in Europe would of course add EU MDR’s. Even more recent, MDSAP will now also need to be included.
In actuality, the true answer is even more complex. 21 CFR 820, and ISO 13485 are only the Good Manufacturing Practice (GMP) portions of the regulation, or the Quality Management System (QMS) requirements of the manufacturing standards. Where are the remaining requirements found?
This webinar will be taking a "birds-eye-view" of the different parts of 21 CFR, as they apply to Medical Device Manufacturing, and also looking at the corresponding articles of (EU) MDR.
We’ll also provide an insight into software solutions for implementing the various requirements and how to keep track of documents, overcoming implementation challenges, and making QMS changes simultaneously.
If you are not a "regulatory guru", but have an interest in knowing about the regulations, attending this short webinar will be an excellent way of getting your feet wet in the regulatory world, without drowning in the details.Register Now