CER support from a team who knows the requirements inside and out.
Our team is led by former notified body leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR. RQM+ is uniquely positioned to help you create a strategy for presenting comprehensive clinical evidence and analysis. We know what notified bodies are expecting, and we will prepare your team and documentation accordingly.

Every Clinical Evaluation Plan that we create balances regulatory, clinical, and business risks and objectives.

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With former notified body leaders on staff including Amie Smirthwaite, former Global Head of Clinical Compliance at BSI, and a team of seasoned experts who have created and received feedback on hundreds of CERs, we have unique insights into what notified bodies will accept and creative strategies for how to respond to nonconformities.

Our global team has a unique combination of clinical and regulatory expertise with a deep understanding of how medical devices work, how performance is measured, and what type of clinical evidence and analysis is required.  

Led by our clinical team project managers, the RQM+ process begins with gaining a thorough understanding of your products, business objectives, and regulatory strategy. With a focus on demonstrating sufficient clinical data, we will help you implement innovative strategies for using existing data to meet reviewer expectations.

RQM+ will create a thoughtful clinical regulatory strategy that is applied throughout the process. This guides the CEP and clinical literature search protocols followed by the compilation of the CER, which includes a comprehensive analysis of all clinical data. We have multiple checkpoints with our clients to maintain alignment, as well as an internal review of the documents to ensure the result meets both your and the notified body's expectations.

Using our clinical evidence matrix and a comprehensive approach to gathering data across multiple departments, we will help you clearly identify gaps and weaknesses in data. We will then help you create a plan for the future, including rationales, justifications, and PMCF planning. Our integrated approach provides a complete picture for reviewers so that they can feel confident in approving the product for CE marking.

Seamless integration of CERs, PMS, and risk management is essential for more than just compliance—it will also save you money. Proper integration ensures data flows consistently across multiple procedures and departments. Why waste valuable resource time by having one department reproduce or reformat data to resolve inconsistencies in procedures and templates? RQM+ will ensure efficiency and effectiveness across the business, reducing opportunities for errors and nonconformities.

Clinical evaluation reports and other documentation must be updated regularly to stay compliant. We can take on routine maintenance on a predetermined schedule so you don’t have to worry about missing deadlines or burdening your internal resources who need to be focused on new products.

Delivery Models

RQM+ offers three delivery models to align with your project's needs and ensure optimal outcomes.

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Full-time or part-time consultant support to address staffing or expertise shortages.
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Full Service
Technical consulting and project management paired with strategic guidance for in-depth CER delivery.
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A streamlined approach providing a single experienced resource to cost-effectively complete your CER.

RQM+ is a strategic partner that adds value to your business by balancing regulatory and clinical needs with business goals.

EU MDR Transition

Demonstration of sufficient clinical evidence is one of the most critical elements to achieving MDR certification, and it extends beyond your CER to risk management, PMS, PMCF, and labeling. The RQM+ MDR implementation team creates technical documentation files that convey a cohesive story of clinical evidence across functions and deliverables. 

Our team has created hundreds of MDR technical documentation files. We continue to receive notified body feedback on these files, which grows our unrivaled collective knowledge. We know what reviewers are expecting.

Learn more about MDR Planning and Execution

Expertly Crafted CERs

The feedback our clients have received speaks for itself—one reviewer said we produced the best CERs they had ever seen, and another used the term “perfect.” We get these results because every CER team has deep knowledge of the expectations of notified bodies; understands what is sufficient to prove safety, performance, and state of the art, and benefits from RQM+ unrivaled collective knowledge.

Learn more about our complete Clinical Evaluation solution

CER Maintenance Packages

The work is not done after certification is granted. Our team can update documents and create reports as new data arises—and periodically as required—so that you are always in compliance. Investing in ongoing maintenance also helps streamline updates to risk management and SSCPs and the creation of PSURs.

Clinical regulatory affairs require specialized expertise and the RQM+ team has it. Whether you want to supplement your internal team, bring us in for complex new products, or hand over maintenance to us, we’re committed to collaborating with you to deliver right-sized solutions.

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Innovative Approach
We have mastered the science and art of creating clinical documents that tell a compelling story.

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Clinical Expertise
Our team is filled with clinicians, engineers, and regulatory experts with experience in a large variety of device technologies.

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Industry Experience
The RQM+ team has firsthand knowledge of the expectations of notified body reviewers.

Video FAQs about CERs

What was the intent behind the MDCG guidance for Biological Equivalence and how did it help?

Equivalence started getting noticed around 2007 and 2008 with some particular device failures. Back then, there was a much lighter approach to biological equivalence. From that time, they determined that they want materials for implants to be the same – not just similar or lower risk.



What have you been hearing from Notified Bodies (SSCPs)?

Notified bodies are really following the guidance closely and pointing out missing sections and are telling manufacturers to go back and fill it out as the guidance says. We are also hearing that you must show quantitative, you cannot just make it qualitative, and it has to be very specific. They are also making sure that the PRRC has signed the document.



We are passionate about your success. Tell us more about your needs so we can help.

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