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ATTENTION:
Medical Device Quality Assurance Professionals

Ticking Clock,
Intricate Process

Is Your Business Ready for
“The QMSR Challenge”?

Don't get caught off guard.

Prepare for a smooth "QMSR Compliance" transition
with our comprehensive 

Gap Analysis Checklist.

Ticking Clock, Intricate Process

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.

The QMSR Deadline is Approaching Faster Than You May Expect!

Although the deadline for QMSR compliance in February 2026 may seem far off, the intricacy of the process can easily cause delays and increase the danger of non-compliance.

 

  • Underestimating the workload: To bridge the gap between existing systems and the new standards, the QMSR's extensive requirements call for a systematic approach.

  • Hidden complexities: Interpreting regulations and integrating QMSR with existing quality management systems can pose unforeseen challenges.

  • The risk of scrambling at the last minute: Rushed implementation can lead to errors and potential penalties.

Be Prepared: Our Gap Analysis Checklist is Your QMSR Roadmap to compliance in 
3-STEPS

Assess Your QMSR Readiness

Bridge the Gap with Our Checklist

Develop a clear action 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.

What do other say about Brian's expertise

Simon Roberts  Sales Director Cognidox

Brian is a fountain of knowledge when it
comes to ISO 13485 implementation.

Edwin Bills ASQ Fellow, RAC, Principal Consultant

This was a comment posted by Edwin on a post I made on LinkedIn covering a major change to the FDA QSR quality and regulatory requirements.

"Now is the time to do a Gap Analysis in your Quality and Risk Management Systems and develop a Quality Plan to meet the new regulation."

Boonsit Chungsirporn  Executive Director TPI Glove Division

Brian Newbery's experience and knowledge of the ISO 13485:2016 quality standard and USA FDA regulations as well as many other international regulations continues to be a major source I go to on a regular basis.

Develop Your Roadmap to
QMSR Compliance with our 3-STEP
Gap Analysis Checklist!

Is your medical device company transitioning to ISO 13485:2016 and the new FDA Quality Management System (QMSR) requirements)?

Our comprehensive Gap Analysis Checklist is the perfect tool to identify any gaps in your current quality management system (QMS) and ensure a smooth transition to QMSR compliance.

Click Here to View Example

Download Example

How it Works

Step 01: Assess Your QMSR Readiness

Don't wait until the clock runs out! This initial step is crucial in understanding your current standing and potential hurdles on the path to QMSR compliance. Here's how we'll help you assess your readiness:

  • Identify Potential Challenges: This checklist will guide you through key considerations to uncover any knowledge gaps or areas where your existing systems might not fully align with the QMSR requirements.

  • Evaluate Resource Needs: * This assessment helps you determine the resources (personnel, training, documentation) needed to successfully implement QMSR within your organization.

  • Uncover Hidden Complexities: Don't underestimate the intricate details. We'll help you identify potential challenges beyond harmonization discussions, ensuring a comprehensive understanding of the QMSR transition.

Step 02: Bridge the Gap to QMSR Compliance

Feeling overwhelmed? Let our comprehensive checklist be your roadmap. This expertly crafted tool empowers you to:

  • Streamline Gap Analysis: Our clause-by-clause breakdown ensures you don't miss any critical requirements from QMSR, and ISO 13485:2016, saving you valuable time and effort.

  • Prioritize Effectively (Optional): * Focus your resources on the most critical areas with our risk-based assessment (optional). This helps you address high-impact gaps first, optimizing your compliance journey.

  • Actionable Insights: * Our checklist goes beyond simple gap identification. We offer potential corrective actions for each identified gap, providing a clear path towards closing them.

Step 03: Develope a Clear Plan of Action

Knowledge is power, but action brings results. * With the gaps identified and prioritized, we can guide you through creating a clear and actionable plan:

  • Define Corrective Actions: Develop a concrete plan for addressing each identified gap. Our checklist provides space to record potential solutions, ensuring a focused approach towards achieving compliance.

  • Set Realistic Timelines: Break down your action plan into achievable milestones with defined timelines. This helps you stay on track and manage the QMSR implementation process efficiently.

  • Empower Your Team: Ensure your team is equipped to execute the action plan. This might involve providing training * or delegating tasks based on expertise and resources.

 

By following these three steps and leveraging our signature Gap Analysis Checklist, you can confidently navigate the QMSR compliance journey and achieve a smooth transition.

OBTAIN YOUR COPY of "The QMSR Gap Analysis Checklist" now at this special introductory price. 
But this rate is subject to change at any time and this Gap Analysis may increase at any moment!

   ORDER NOW, and get started on accessing your QMSR Readiness!

  ORDER NOW, so you can start bridging the gap to QMSR Cmpliance!

  ORDER NOW, to develop your clear plan of action!

I understand that by placing my secure order today, I will be getting instant access to the QMSR to Compliance Roadmap in the form of a 41 page Gap Analysis Checklist (easy to edit on any computer no additional software needed).

1 Single Payment of

$159.00

* Completed on a live call which is included in this package.

We are confident that you will be satisfied with our product, but if for any reason you are not, we offer a 90-day money back guarantee. This means that you can return the product within 90 days of purchase and receive a full refund. We value your trust and loyalty, and we want to make sure that you have a positive experience with us. To claim your refund, simply contact our customer service team and provide your order number and proof of purchase. We will process your request as soon as possible and issue your refund within 10 business days according to the stated in our refund policy.

We Eliminate Your Risk ...
We Guarantee Your Satisfaction!

Purchase the Gap Analysis Checklist, use  it, absorb it and follow our advice. If you are not completely satisfied with our QMSR to Compliance Roadmap, we will return all of your money!  It's really that simple.  If after 90 days from the date of your purchase if you are not completely satisfied with your purchase, just let us know, and we will issue a refund as long as it is before the 90-day limit according to our refund policy.