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Get Expert Guidance for Your ISO 13485 Journey and QMSR Compliance Success
(with Peace of Mind)

Choose the Right Retainer Package to Achieve Your Medical Device Compliance Goals

Brian Newbery, a leading ISO 13485 consultant, understands the unique challenges you face in bringing your medical device to market, including navigating the ever-evolving regulatory landscape and ensuring a smooth transition to the new Quality Management System Regulation (QMSR).

Whether you're seeking certification to ISO 13485 or working towards QMSR compliance, this retainer program provides the ongoing support and guidance you need to achieve your medical device quality management goals.

How It Works

1

Select the retainer package that best fits your needs (3, 9, or 18 hours per month).

2

We'll develop a customized plan based on your specific project goals.

3

Brian will be readily available to answer your questions and address any roadblocks throughout the month.

4

Gain access to Brian's expertise whenever you need it, for the duration of your retainer agreement.

Our retainer packages provide you with ongoing access to Brian's expertise, allowing you to:

  • Gain a clear understanding of the ISO 13485 Standards and the new QMSR requirements.
     
  • Develop a customized implementation plan tailored to your company's needs.
     
  • Bridge any gaps in your current quality management system (QMS).
     
  • Feel confident in your company's readiness for an ISO 13485 or FDA audit.
     
  • Have a trusted advisor to guide you through the complexities of ISO 13485 compliance and/or QMSR implementation.
     
  • Receive ongoing support to ensure you stay on track and avoid costly delays or gaps in your QMS
     
  • Have peace of mind knowing you have a qualified expert in your corner.

Retainer Packages

Choose the package that best suits your project needs

Essential Support

(3 hours per month): 

 $300

/ mo.

Ideal for companies in the early stages of their ISO 13485 journey, or for established companies who need guidance on the transition to the new QMSR requirements.

This package provides time to discuss your QMSR gap analysis, identify key changes to your QMS, and develop a plan for implementation.
 

Perfect for ongoing Q&A and clarification of specific requirements.

Standard Support

(9 hours per month): 

 $765

/ mo.

A perfect fit for companies actively engaged in developing or improving their quality management system (QMS) to meet ISO 13485 and/or QMSR requirements.

This package provides dedicated time for document review, gap analysis, and implementation support, ensuring your QMS is robust and meets regulatory standards.

Premium Support

(18 hours per month): 

 $1350

/ mo.

The most comprehensive option for companies with significant changes to implement and looking for a fast-track implementation.

Also those nearing their ISO 13485:2016 certification audit or approaching the QMSR effective date.

* Advertised rates are limited to remote consulting and not applicable for  project-specific consulting. Project-specific consulting rates are estimated based on the project's scope.

Still unsure which package is right for you?

Schedule a free consultation with Brian to discuss your specific needs and create a customized plan.

What's Included in Every Retainer Package:

  • A dedicated point of contact with Brian Newbery, a highly experienced ISO 13485 consultant.
  • Monthly progress reports to keep you informed and on track.
  • Direct access to Brian via email, phone or online call, for your ongoing questions and concerns.
  • Access to a library of helpful resources, templates, and tools.

Proposal Agreement:

A detailed proposal agreement will be provided outlining the specific services included in your chosen retainer package. This agreement will clearly define Brian's and your responsibilities, as well as the retainer term and expiration date.

Ready to Get Started?

Don't wait to achieve your ISO 13485 certification goals and/or QMSR transition. Select your retainer package today and ensure a smooth and successful journey towards regulatory approval.