This five-day seminar addresses all of the elements of the ISO 14971:2019 Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process. An overview and examples of the Risk Analysis Tools listed in ISO/TR 24971:2019.

This seminar will also provide a hands-on experience with the linkages between various aspects of the Advanced Product Quality Planning (APQP) process. Specifically, the development and linkage of Block Diagrams, Interface Matrix, System and Design FMEAs and Design Verification (Test) Plans (DVPs), as well as planning and developing the manufacturing system and processes in preparation for a product launch as well as the management of continual improvement.

This class includes breakout exercise sessions using an example of a Medical Device sub-assembly project and product launch.