Online & On-Site Training Options

 

Online (Virtual Classroom) Design Control & Risk Management Training

Procenius's online courses provide a convenient and low-cost alternative to the on-site training but with the same high quality training experience. The courses are taught live by the same instructors as onsite courses. All aspects of the onsite courses are provided during the online experience including: significant attendee and instructor interactions, discussions, quizzes, group breakout sessions, workshops and exercises. 

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On-Site & Customized Design Control & Risk Management Training

Procenius provides the most customized on-site (private) design control (FDA & ISO 13485) and risk management training available. Our instructors research our client's products prior to the training. The products are used during the course exercises, workshops and examples to ensure an enriching training experience. General design control principles are taught and then applied using actual client examples.

On-Site Group Training

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Courses

Design Control & Risk Management Training (combo course)An Integrated Product Development Approach (ISO 13485 & 14971 & FDA 21 CFR 820) -  Agenda

Design Control Training- Basic/Intermediate: Practical Implementation and Compliance Best Practices (FDA 21 CFR 820) -  Agenda

Risk Management Training - Basic/Intermediate: Implementing the Risk Management Process and Risk Assessment Development (ISO 14971) - Agenda

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Included with Each Course

Free Design Control & Risk Management Handbook

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Additional Informatrion

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.

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