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Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).
The systems share many similar features but they are not identical. Could we have on the same site a QMS that complies with both requirements? Must we have one QMS that's complies with both, or we could have two QMS coexist on the same site? To answer it we should discuss the background of both documents, their legal status, what is expected by the regulatory authorities and some basic concepts in quality and medical devices quality in specific.
We should understand what is required by both, what is just semantically named differently and what is principally different between both documents. For instance, ISO requires quality manual (QM) while such term does not mentioned in the FDA QSR but policies and standard operating procedures, this can be settled relatively easy. Other issues requires more attention. We will point out the main features and what should be done from an aspect of a site or a manufacturer which wants to comply with both QMS.
Why should you Attend: For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.
Areas Covered in the Session: