QMSR Masterclass - Everything You Need to Know

3 reasons you need to watch this webinar:
1. The 70-page preamble to QMSR, which FDA refers to repeatedly, even though the preamble is considered "recommendation"
2. Then we have the Practical Guide to 13485, which is also not regulation
but expectation.
3. The FDA can now inspect Management Review, Internal Audit and Supplier Audit records.
And all of this could change in a few years, when ISO 13485 is updated and (potentially) drifts out of alignment with QMSR. Again.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501k, medical device regulation, FDA 510(k), FDA 510k clearance, regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, FDA pre submission, regulatory compliance, FDA submission, FDA 510k submission guidance, quality, quality management, quality system, quality management system, ISO 13485