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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • On-demand Webinar

IEC 60601-1, Fourth Edition: What to Expect

The upcoming fourth edition of IEC 60601-1 introduces major updates to regulatory expectations for medical electrical equipment and systems that may impact device design, documentation and compliance.

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THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Key topics covered during the webinar

  • Reorganization of general requirements by source of harm
  • Integration of collateral standards into the base standard
  • Removal of obsolete technologies
  • Incorporation of evolving technologies in the programmable electrical medical system (PEMS) area, particularly cybersecurity and artificial intelligence
  • Updated patient classifications and use environments
  • Anticipated timeline for publication of the fourth edition
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