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.

You can also subscribe to our unique Standards Navigator subscription or our concierge level Standards Navigator PLUS subscription at our Subscribe page.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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