Onsite/Custom Training

Procenius provides the most customized design control 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 examples including:

  • User need & design input development
  • Design output identification
  • Design transfer process development
  • Verification/Validation methodology development workshops
  • More...

The risk management course includes using our client's products in exercises and workshops to:

  • Identify Hazards & Hazardous Situations
  • Evaluate Risk
  • Control Risk
  • Perform Risk Analysis and Risk Assessments
  • Mitigate Risk
  • Fault Tree Analysis
  • More...


Flexible Agenda

The course agenda can be modified to meet the needs and understanding level of the attendees


Available Courses

Design Controls (21 CFR 820.30 & ISO 13485) - Practicable    Implementation and Compliance Best Practices. Learn more and register...

Risk Management (ISO 14971:2007/2012) - Implementing the Risk Process Management and Risk Assessment Development. Learn more and register...

Contact Us For A Quote...

Contact us for a quote for on-site/custom design control or risk management training now!

Design Controls Training

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

Procenius's 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 learning which 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 Control - Attendees of the design control class will actually implement the design and development process by using a case study to develop design inputs, outputs and verification/validation strategies.
  • Risk Management - This class 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 8-15 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 - Classes 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.

Contact Us For A Quote...

Contact us for a quote for on-site/custom design control or risk management training now!