Product Details
Medical Device Supplier Quality Management
Purchasing controls and supplier management continue to be target-rich environments for FDA investigators.
And to make things more complicated, the ISO 13485:2016 standard was released and you must make sure your supplier quality procedures are compliant with these new standards.
In order to avoid citations you need to ensure your supplier quality related procedures are compliant with ISO 13485:2016 and Part 820.50. Without guidance you can be in for plenty of headaches and complications.
Join expert Jim Shore — Director of Quality at Titan Medical, Inc. — for an overview and up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices.
This session will cover the top three supplier controls changes you need to make this year including:
- Performing a gap assessment to the new ISO Requirements and QSR expectations
- Reviewing Supplier Quality Agreements for key elements
- Performing and documenting Risk Assessment of Suppliers using the Total Risk Factor™
Order today and know how to implement procedures necessary to manage your suppliers and remain in compliance.