Risk-Based Thinking for Medical Device Management Personnel
The most important ingredient of an effective “risk-based thinking” implementation 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 many sources of risk exposure. The class will begin with a definition of risk and how risk is reduced. The class will then identify the five sources of risk that all companies who design and manufacture medical devices face during the product life cycle and the tools that are available to reduce or eliminate them. 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 tool in managing risk will also be identified.
The Key role that managing risk in the Product Lifecycle plays in meeting the risk-based thinking requirements of ISO 13485:2016 will be explained.
Who Should Attend
All management personnel who manage personnel involved in the Medical Device design and manufacture should attend the class.
Key Concepts Covered:
- Definition of Risk;
- Five major sources of Risk;
- Definition of Risk Based PLM® (RBPLM®) and how it helps a company reduce Risk;
- The four major risk reduction tools of RBPLM® and their roles (Requirements Risk Assessment (RRA®), Design FMEA (System, Subsystem, Component), Process FMEA and Application FMEA);
- Overview of how RRA® is conducted;
- Key support tools of a properly conducted RRA®;
- Overview of how Design FMEA (System, Subsystem, Component) is conducted;
- Key support tools of properly conducted Design FMEA®;
- Overview of how Process FMEA is conducted;
- Key support tools of a properly conducted Process FMEA;
- Overview of how an Application FMEA is conducted;
- Key support tools of a properly conducted Application FMEA;
- Linkages between the major risk reduction and support tools of RBPLM®;
- Resources required to implement RBPLM®;
- Obstacles to implementing RBPLM®;
- The relationship between ISO 9001:2015 and RBPLM®.