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13485
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...
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Click here to view a summary of my highlights and rationale, along with some practical implementation tips for the new ISO 13485:2016:  SoftwareCPR-ISO13485 revision March 2016 highlights Some of the revisions add items included in FDA’s 21 CFR 820 Quality System Regulation such as Design Transfer, Validation of automation of quality system activities, detailed records, and...
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This content is only available to our Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. Read the Swedish formal objection to the harmonization of ISO 13485. Sweden Formal Objection ISO13485 Medical Devices
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The Industry response to the Swedish objection to ISO 13485 can be found at the following link:   Industryresponseto13485objection I had previously posted regarding the Swedish objection at this link:  
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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