ISO 62304 – Software Life Cycle Processes, the Challenges for Medical Devices

Software engineers and QA specialists reviewing code and test results on screens near a medical device

WEBINAR · ON-DEMAND

This presentation introduces Ametek/Rauland and its medical device products, focusing on the company’s journey to continue to strengthen its level of compliance with ISO 62304. The session examines software life cycle compliance requirements relevant to healthcare and education communication systems manufacturers.

Key Takeaways

  • Overview of Ametek/Rauland and its medical device product lines
  • ISO 62304 software life cycle process requirements for medical devices
  • The company’s journey toward strengthening ISO 62304 compliance
  • Challenges specific to healthcare and education communication systems manufacturers

Speakers

Peter Bovenzi

Peter Bovenzi

Global Chief of Engineering Excellence, BorgWarner PowerDrive Systems

Peter Bovenzi is the Global Chief of Engineering Excellence at BorgWarner PowerDrive Systems, working in electrified propulsion product development. His 39-year automotive career spans roles at GM, Delphi, Delphi Technologies, and BorgWarner across eight technical centers in the US and Mexico, holding various product, systems, and manufacturing engineering positions. He holds a BS in Electrical Engineering from the University of Dayton and an MS in Electrical Engineering from Purdue University (GM Fellowship recipient).

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