Onsite/Custom Training

Benefits Of Attending Medical Device Design Control & Risk Management Training (FDA, ISO 13485, ISO 14971)

• Procenius specializes in on-site FDA / ISO 13485 design control training, risk management training and consulting
• Our instructors developed customized design control training materials to ensure an effective workshop experience
• A 10% discount is available now until Jan. 31st 2019
• Each attendee receives a free exhaustive design control and risk management handbook (440 pages, $170 value on Amazon)
• A combo course is now available which integrates design control and risk management concepts into the product lifecycle is now available
• Added bonus: Each client will receive free consulting hours as part of the training package to answer follow design control needs

Hands-On Workshops, Small Class Sizes, Open Discussion Training

Procenius's medical device design control training and risk management training workshops use a balanced learning approach to consistently engage attendees to ensure an effective learning experience using multiple teaching techniques. Typical classes experience one-third lecture, one-third hands-on workshop time and one-third open discussion. This teaching method enables principles and concepts to be solidified with real-life examples and hands-on applications.

All of Procenius's workshops are taught by medical device design control and risk management experts with both engineering and business backgrounds/education that have extensive experience with hands-on, practical implementation of design control and risk management techniques.

Hands-On Workshops

• Design Controls & Risk Management - An Integrated Product Development Approach  -This combo design control training and risk management training course integrates design control and risk management principles into a simulated medical device development life cycle. This course is ideal for medical device professionals developing new products and would like to gain a clear understanding of how design controls and risk management should be integrated into the product lifecycle.

• Design Control Training - This design control training course focuses on design control regulation and principles which are reinforced with workshops, exercises and quizzes. Intended for medical device professionals with basic to intermediate knowledge of design control.

• Risk Management Training - This risk management training course begins with a review of concepts and principles in ISO:149871:2007 (& EN ISO 14971:2012) and then allows attendees to implement a full risk assessment including hazard identification, risk evaluation, controls identification and risk mitigation. 

Small Class Sizes - Classes sizes are typically 5-10 attendees to allow for a one on one learning environment where attendees and the instructor can freely interact to allow a real-time learning and feedback experience.

Open Discussion/Consulting Environment - Design control training and risk management training courses are structured to allow attendees to ask specific questions about the design and development challenges they are currently facing with their own medical devices. This approach becomes a learning-rich environment which allows the entire class to benefit from using real-world examples and over-coming real-world problems.