ISO 13485:2016 Deadline nearly upon us…

ISO 13485:2016 Deadline nearly upon us…

The three-year transition period of ISO 13485:2016, “Medical Device – Quality Management Systems – Requirements for regulatory purposes” will conclude on February 28, 2019. Specifically, organizations’ ISO 13485:2003 certificates will no longer be valid as of March 1, 2019. ComplianceAcuity clients have already achieved multiple transitions to ISO 13485:2016 with ComplianceAcuity’s help and leading transitional tools and resources. Please contact us for more information on how we may be able to help you complete your transitions by the deadline.


10.16.2018
U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity…

Links to the draft guidance and corresponding Federal Register notice are provided below:

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf


https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance

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