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This course also features a 30-minute session with our star instructors, Mike Down , Mary Rozwee and Greg Gruska who will share insights on the standard and key industry updates.
Course Duration: 5 Days - 8 Hours/day
This five-day training course 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 course 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.
Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.
Each participant will receive a seminar manual and a workbook including all team breakout exercises.
Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.
No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.
ISO 14971 Risk Management Training with DFMEA and PFMEA Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.