17 Oct 2011

Over the last weeks, several of our experts have been asked questions regarding how and when compliance with ISO 14971 will be evaluated for 60601-1. To better address these questions, the blog entry for today will provide an overview of the three step process that Intertek follows when helping customers review their Risk Management Files.

  • Step 1 - Review the Risk Management Process Files (SOPs, Work Instructions, etc.) against the requirements in ISO 14971: 2007
  • Step 2 - Review the Risk Management File for the product under evaluation against the companies risk management process
  • Step 3 - Review the Risk Management Requirements of IEC 60601-1: 2005 to see that applicable hazards from the standards have been addressed in the Risk Management File for the product

If you have a questions for our technical expert, Todd Konieczny, North American Medical Technical Leader, please send an e-mail to ThirdEdition@intertek.com. Additionally, you also may visit https://www.intertek.com/medical/ to learn more about this subject.

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