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.