Attention: Medical Device Quality Assurance Professionals
support@fasttrackiso13485
The Clock Is Ticking!
Is Your Business Ready for
“The QMSR Challenge”?
Don't get caught off guard. Prepare for a smooth QMSR transition
with our comprehensive Gap Analysis Checklist.
support@fasttrackiso13485
The QMSR Effective Date is Approaching!
Just over 18 Months Left
Although February 2, 2026, may seem far off, don't underestimate the potential for significant changes you may need to make to your current quality management system to meet the QMSR and by reference the ISO 13485:2016 requirements.
Start now with 4 basic recommended steps:
- 1 - Understand QMSR and ISO 13485:2016 Implementation Requirments
- 2 - Gap Analysis and Planning
- 3 - Implementation / Transition
- 4. Internal Audits and Corrections
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Underestimating the workload: To bridge the gap between existing systems and the new standards, the QMSR's extensive requirements call for a systematic approach.
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Hidden complexities: Interpreting regulations and integrating QMSR with existing quality management systems can pose unforeseen challenges.
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The risk of scrambling at the last minute to achieve QMSR compliance: Rushed implementation can lead to errors and potential penalties.
Be Prepared: Our Gap Analysis Checklist is
Your QMSR Roadmap To Compliance In
3-STEPS
Understand QMSR Requirments
If you do not already have, obtain and read copies of the QMSR Final Rule and the ISO 13485:2016 Standard until you have a good understanding of the detailed requirements.
You will also want to refer to the ISO 13485:2016 Standard for specific requirements as you complete the Gap Analysis.
Complete QMSR Gap Analysis with Our Checklist
Go through each page of the 41-page checklist and QSR section along with the corresponding ISO 13485:2016 and QMSR notes in the checklist column and compare them to your current quality management system documentation. For any gaps make a note in the QMSR column.
Develop QMSR Transition and Implementation plan
Once all the gaps in your current QMS are found and recorded on the checklist you can use this information to develop your QMSR Transition and Implementation Plan.
Expert Insights About
QSMR Compliance
Meet Brian Newbery the expert behind the Checklist,
with over 25 years of industry mastery.
My experience of over 25 years leading the implementation of many quality management systems, and as a consultant helping medical device companies with their ISO 13485:2016 quality management system implementation, I have continued to be totally convinced that completing a Gap Analysis and Implementation Plan before starting the actual QMS implementation, is essential to the success of the project.
The good news for all of you is that I learned this myself the hard way. My very first complete quality system implementation I did the first thing right and purchased a copy of the Standard. But then skipped the gap analysis and planning steps and dived right into the actual implementation. Result was missed gaps, underestimated implementation time and resources needed, and so missed the certification target by many months.
GET YOUR COPY TODAY!
Of The QMSR Gap Analysis Checklist
And Develop Your Roadmap
to QMSR Compliance
For Just $59.00
I Understand By Placing My Secure Order Today I Will Be Getting Instant Access to the 41-page QMSR Gap Analysis Checklist (Easy to Edit and Add Notes on Found Gaps in Our QMS To Meet The QMSR and ISO 13485:2016 Requirements.