Mark Leimbeck, UL

Consistency Needed in Addressing IEC 60601-1 3rd Edition Risk Management

By MedTech Intelligence Staff
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Mark Leimbeck, UL

There’s a greater emphasis on being able to demonstrate competence in performing required activities.

During MedTech Intelligence’s recent conference on risk management, experts discussed a range of issues, from patient, clinical and engineering perspectives to evaluating and integrating risk management into various functions within a company. During an interactive panel, Jon Speer, founder & VP QA/RA at greenlight.guru, asks Mark Leimbeck, program manager at UL EduNeering to touch on the third edition of IEC 60601-1 and the risk management requirements.

“One of my biggest concerns was consistency,” said Leimbeck. “Making sure that if we had a client who walked in the door in Taiwan they got the same opinion as the person who walked into our office in Melville, New York as in Frankfurt, Germany.” Watch the video for the rest of Leimbeck’s insights.

 

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