ISO 13485:2016 Highlights

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 others.

As part of our RegulatoryCPR services we can assist you in your gap analysis and interpretation of this new revision.  Although many know SoftwareCPR as experts in software related regulation, compliance, and safety, we also have a long track record providing expert consultation, training, and negotiation with regulatory authorities (including FDA enforcement actions) related to Quality System requirements, including international standards, and premarket submissions.  Our focus is on efficient compliance and product safety and effectiveness and we can assist you in planning for implementation of this new version of 13485 including applying risk management to its interpretation.

For more information contact Brian Pate at 781-721-2921 or brian@softwarecpr.com.

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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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