Risk Based Medical Device Lifecycle Management™ for Management Personnel


The most important ingredient of an effective Medical Device Risk Management System in company is a management that believes the Risk Management System is critical to the company’s success and supports it through daily actions and by allocating resources to it. Before one can believe in something, they must understand it. The objective of the class is to provide a reason for management believing in the importance of a strong Risk Management System to the company’s success.

The Product lifecycle for a company that designs and manufactures Medical Devices contains five core sources of risk exposure. The class will begin with a definition of the core sources of risk. After defining the core sources of risk, the class will introduce the attendees to a structured methodology known as Risk Based Medical Device Lifecycle Management™ (aka Risk Based MDLM™) for reducing them. Risk Based MDLM™ involves the use of four, integrated risk management tools. The attendees will be taught how the risk management tools work and the key steps required to use each one correctly. The common mistakes people make when using the tools that lead to a reduction in the effectiveness of the tools in managing risk will also be identified.

Finally, the Key role that managing risk in the Product Lifecycle plays in meeting the Risk Based Medical Device Lifecycle Management requirements of ISO 13485:2016 and ISO 14971:2019 will be explained.

Who Should Attend:

All management personnel who manage personnel involved in the product design and manufacture of Medical Devices should attend the class.




One day.


Key Concepts Covered:

  1. Definition of Risk;
  2. Five major sources of Risk;
  3. Definition of Risk Based MDLM™ and how it helps a company reduce Risk;
  4. The four major risk reduction tools of Risk Based MDLM™ and their roles: Design Input Risk Assessment™ (Design Input RA™), Design Output Risk Assessment™ (Design Output RA™), Process Risk Assessment™ (Process RA™) and Usage Risk Assessment (Usage RA™);
  5. Overview of how Design Input RA™ is conducted;
  6. Key support tools of a properly conducted Design Input RA™;
  7. Overview of how Design Output RA™ is conducted;
  8. Key support tools of properly conducted Design Output RA™;
  9. Overview of how Process RA™ is conducted;
  10. Key support tools of a properly conducted Process RA™;
  11. Overview of how an Usage RA™ is conducted;
  12. Key support tools of a properly conducted Usage RA™;
  13. Linkages between the major risk reduction and support tools of Risk Based MDLM™.
  14. Resources required to implement Risk Based MDLM™.
  15. Obstacles to implementing Risk Based MDLM™.
  16. The relationship between ISO 13485:2016, ISO 14971:2019 and Risk Based MDLM™.

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I have been working with Harpco Systems for 20 yrs and have seen how their products and services continue to improve to meet customer demands. Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.

Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrastructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
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