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.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.