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Thu Jun 11
  • Webinar

Clearing up the confusion around 60601-1 Amendment 1 and Risk Management

  • Webinar

There continues to be confusion over expectations for manufacturers implementing a risk management process to satisfy IEC 60601-1 and Amendment 1.  Unfortunately, because the 60601 Standard is a type test standard, and necessarily eliminated reference to Clause 9 in ISO 14971 on Post-Production Information, some manufacturers have interpreted this to mean that they need not satisfy this Risk Management requirement.  However when taking a larger view and placing the standard in the context of the entire Regulatory environment and the needs of a Quality Management System, the criticality of this vital feedback loop becomes clear.  This presentation will seek to clarify the role of the ISO 14971 requirement for assessment of Post-Production Information, and how it can be used to support, and even drive, a living and fully compliant Quality Management System satisfying both the FDA Quality System Regulation and ISO 13485.

Date: Thursday, June 11th

Time: 11:00 am EDT

Location: Your Internet Device

Cost: FREE

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