Regulatory affairs support that goes beyond submissions
RQM+ has worked in every clinical specialty and has the leadership and expertise to get your safe and effective product(s) to market. Our risk-balanced approach and strategic direction contribute to positive business impacts and set your organization up for greater success.

Leading industry experts will offer wisdom, honesty, and friendly collaboration at every turn, making for a rewarding partnership centered on your success.

    medical devices

Our global team is comprised of engineers and scientists who understand how medical devices work, how performance is measured, and what type of documentation and evidence is required. With former regulators and notified bodies on staff, we have unique insights into how regulatory bodies and reviewers are likely to respond.

The unrivaled collective knowledge at RQM+ allows us to provide expert support for regulatory submissions, including EU MDR, FDA 510(k), PMA, De Novo, IDE, EUA, breakthrough, and Q-submissions. All clients benefit from our systematic approach to sharing information and knowledge while also ensuring client confidentiality.

RQM+ has expert implementers with experience in transitioning multinational organizations to EU MDR for all device classes. From strategic planning to tactical execution, we apply our client-validated transition processes, procedures, and tools to acquire or maintain CE marking and keep your product on the market.

Learn more about CE Marking

Our engineers and scientists do more than review and compile data—they play an active role in new product development teams from the beginning. Services include developing and updating regulatory strategy, aligning regulatory activities and business strategies, evaluating risk, providing regulatory review and input on product development documentation, and creating an efficient pathway to market.

Acquiring an existing product line can easily overwhelm internal regulatory affairs resources that are already fully allocated. The seasoned experts at RQM+ can handle due diligence, remediation of documents, product evaluation, labeling, manufacturing transition, and any other steps required for compliance, harmonization, and integration.   

Companies with multiple product lines typically do not have the capacity to handle all aspects of regulatory affairs simultaneously. We balance regulatory risk with your business goals to provide strategic direction on complex regulatory challenges and help you prioritize product updates and launches to meet evolving regulations and standards.

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expert support

Subject Matter Expert Support

Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines. 

regulatory leadership

Regulatory Leadership

When you need seasoned regulatory affairs leadership on a significant project such as the transition to EU MDR, we’ll provide trusted leaders to put your mind at ease. 

Project Management

Project Management

For large projects, RQM+ project managers work with you to define the scope, develop the plan and schedule, and lead the team to ensure the project is delivered with efficiency and success.

We bring more than just technical expertise to the table. When you work with RQM+, we’re an extension of your business.

Learn more about the RQM+ approach

As a strategic partner we provide business value with outsourced resources who deliver full implementation from strategy through detailed tactical execution.

Complete MDR Transition

RQM+ provides project management, technical leadership, and expert implementers. We have project managers on staff who have worked on MDR implementations from start to finish. Our technical leaders know what questions notified bodies are asking, how closely guidance documents are being followed, and how the regulation is being interpreted. Our integrated implementation approach links all aspects of MDR compliance, including clinical evaluation plans and reports, risk management files, technical documentation, and PMS.

Learn more about MDR Planning and Execution

Regulatory Compliance

We have created hundreds of technical documentation files across all device classes. Our global team has the clinical and regulatory expertise to ensure your documents meet the evolving standards of reviewers.

Learn more about Technical Documentation

Regulatory Intelligence Monitoring

The global medical device regulatory landscape is constantly evolving. RQM+ monitors legislation implementation, new guidance, industry calibration, notified body feedback, and lessons learned from all clients and projects throughout the world.

We bring more than just technical expertise to the table. When you work with RQM+, we are an extension of your business.

Industry Leadership

Industry Leadership
Former FDA CDRH and notified body leaders on staff can provide valuable insights into reviewer expectations.

Client-Validated Processes

Client-Validated Processes
Constantly evolving best practices and collective knowledge ensure an efficient path to compliance.

Innovative Approach

Innovative Approach
Our wider strategic view improves processes and allows you to anticipate future needs

Explore Medical Device
Regulatory Affairs by Region

Medical Device Regulatory Affairs in the US

From leading pre-market strategy to ensuring post-market compliance and all of the regulatory submissions in between, RQM+ supports regulatory affairs teams throughout the product life cycle. With former FDA regulators on our team, we know what reviewers look for. This allows us to draft submissions that generate fewer questions and helps get your products to market faster.

Medical Device Regulatory Affairs in the EU

The European Union Medical Device Regulation of 2017 (MDR) caused a major shift in the industry, leaving many manufacturers struggling to comply. RQM+ has been involved from the beginning, providing complete transition solutions that allow our clients to keep their products on the market. Having former notified body leadership on the team gives our expert implementers valuable insights into successfully transitioning multinational companies with complex and legacy devices.    

Global Medical Device Regulatory Affairs

RQM+ has experience in regulatory affairs throughout the world. RQM+ works with your in-country representatives to identify requirements and submission or registration strategies, and interprets those requirements for your product development teams to ensure the design and testing will meet the expectations of the regulatory bodies and your device will be globally marketed.

Video FAQs: Medical Device Regulatory Affairs

What's new in digital health at the FDA?


What are some tips from RQM+ former FDA CDRH and SMEs on good letter to file documentation? (Note, a letter to file documents the reason for not filing a new 510(k) submission for a product change)

Start with FDA Guidance, "Deciding when to submit a 510(k) for a change to an existing device". In your letter to file, provide detail of your changes, and document a strong justification and your best argument for why your justification is adequate. Do not just create a checklist from the guidance and check the boxes that apply. It's much harder to defend your decision in an audit if the letter to file contains only checked boxes rather than details of why the decision was made. And include engineering level detail in the justification. Also remember that the letter to file should be based upon cumulative changes since the submission. Be very cautious of cumulative changes, and as regulatory, take a stance when it's time to submit.



How to receive an RTA (refuse to accept) from FDA on your 510(k) submission?

FDA's current 510(k) Refuse to Accept (RTA) policy includes an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days after receipt of the submission if the submission is administratively complete, or if not, to identify the missing element(s). Our former FDA CDRH advise that using the RTA checklist (contained in the RTA policy guidance document), filling it completely with submission page numbers, and including that in the submission is an excellent and efficient way to avoid an RTA. They also recommend that Regulatory treat review of the submission like a design review, with a detailed cross-functional review of quality, completeness, and readability of the submission, including have an independent review provided by someone with fresh eyes on the documentation.



Are there any FDA or Notified Body stories you want to share? What surprises have you had?

Be very clear on why you are making changes. For example, communicate if you are making changes to meet regulations in other countries to avoid help reduce review delays.


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