Insider’s look at the IEC 60601 Amendments: Detailed Guidance from the Committee Member Responsible for the Changes

It's becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape.

With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC 60601 series is massive, creating a swell of confusion around understanding the updates and how to transition for compliance.

We've teamed up with Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendment Project.

This in-depth webinar will cover clarifying details around the massive changes of the IEC 60601 Amendments, provide guidance on the updated standards already published, insider knowledge into the updated standards not yet published and what to expect, and how to prepare accordingly for the impact it will have on your firm and product lines.

SOME OF THE CHANGES WE WILL COVER INCLUDE: 

• Updates to IEC 60601-1 (Medical Electrical Equipment)
• Updates to IEC 60601-1-2 (EMC)
• Updates to IEC 60601-1-8 (Alarms)
• Impacts of standard changes on:
  • Design
  • Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
  • Safety certifications
  • Labeling / markings / packaging
  • Tests/ retesting
  • Essential Performance
  • Risk Management File
  • Usability Engineering File
  • Software Life Cycle Process
• Q&A session

Who should attend?

• R&D Engineers and Management

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Medical Device Executives

• Clinical Affairs Professionals and Management