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WEDNESDAY, DECEMBER 7, 2011
Choices – IEC 60601-1 3rd Edition and Component Selection:
Speaker: Mark Leimbeck, P.E., Program Manager, Health Sciences, Underwriters Laboratories Inc.
ABSTRACT :

With publication of the 3rd edition of IEC60601-1, a new generation of standards began; those that incorporate the concept and application of risk management in the design and production of devices. Implementation of risk management places specific responsibilities on the end-product manufacturer; this has attendant consequences for the component provider as well, and further cascades through the entire supply chain. Thus, formal incorporation of risk management into the standards presents the end-product manufacturer and the component manufacturer alike with a series of choices and opportunities; specifically, how best to insure preservation of basic safety and “Essential Performance” from design through production and end-of-life for a medical device. This presentation explores some of the choices, and implications of those choices, following the risk management process required by the 3rd edition of IEC 60601-1.

  • Background on the standard – the source of the risk management requirement and the intent.
  • Certification options in assessment and licensing of components.
  • The roles and responsibilities of both component and end-product manufacturers in risk management.
  • Conclusion


ABOUT THE SPEAKER:

Mark Leimbeck is Underwriters Laboratories’ Quality and Training Program Manager for Medical Certifications. His current responsibilities include development of an overarching Certification Model for medical devices, encompassing both Regulatory and Safety, as well as coordinating implementation of the model globally.

Mark has more than 30 years of experience at UL working in a variety of roles, including Operations Manager, Principal Engineer for a variety of product categories and representative on US National and International Standards writing committees. He is currently serving as a UL delegate to the IECEE (CB Scheme) Risk Management Task Force.

Mark has served as Project Manager for multiple process improvement initiatives. He led development of, and has contributed to, several training and development programs at UL including quality, technical and management training courses. He has authored and co-authored numerous technical articles, and recently joined the editorial review board for Medical Devices and Diagnostic Industry magazine.

Mark is a member of the American Society for Quality, Regulatory Affairs Professionals Society and is a Registered Professional Engineer. He earned a Bachelor’s Degree in Electrical Engineering Technology from Southern Illinois University and a Master’s Degree in Business Administration from the University of Chicago.



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