Our powerhouse team includes former notified body leaders, regulatory experts, medical doctors, clinicians, statisticians, and device technology experts that cover every type of medical device.
The team is led by Dr. Amie Smirthwaite, recent Global Head of Clinical Compliance at BSI, who was a member of multiple ISO technical committees and provided significant contributions to the European Commission Clinical Investigations and Evaluations Expert Group, including subgroups which authored multiple MDCG guidance documents on clinical evaluation and PMCF topics.
Our team members understand the intent behind the regulation and what notified body reviewers expect to see. With RQM+ as your strategic partner, you can expect see fewer notified body questions and faster time to certification.
Our objective is always to provide a complete and cohesive story of sufficient clinical evidence in your technical documentation. The CER, PMS, PMCF, risk file, and IFU must all be singing in harmony, providing the notified body reviewer with confidence in your evidence and path forward. Our finely honed processes and tools ensure clarity and consistency across all documentation. We also use multiple checkpoints to ensure alignment and quality control checks to verify accuracy.
We create a clear mapping between the intended use and the evidence for demonstration of clinical conformity via a clinical evidence matrix. This is the single most effective tool for not only justifying that you have sufficient clinical evidence, but also the adequacy of your PMS/PMCF plans.
We streamline the gap analysis process so we can efficiently identify areas of weakness in clinical evidence across product claims and indications and create a plan for filling the gaps. We also employ project management tools and software such as Distiller, Embase, and a range of platforms to perform thorough literature searches and associated tasks to create comprehensive CERs.
Our experts will help you develop a clinical evaluation strategy to achieve your business objectives and notified body approval.
We provide innovative strategies for using existing data along with your PMCF plan based upon our experience with a wide range of notified bodies.
From CEPs to SSCPs, we enable you to tell a compelling story, making your documentation appealing to regulators.
Our integrated approach reduces time to certification with fewer notified body questions and nonconformities.
CERs cannot be created in a bubble by the clinical team. There are inputs and outputs between clinical, post-market surveillance, and risk management. Integrating the processes optimizes resources and reduces the risk of audit findings. Our experts will help you update and revise your quality system so that all your processes are working together efficiently. This will ensure that you can meet the requirements of the MDR now and in the future.
The notified body may not interpret the MDR's requirements in the same way you do and you only have three rounds of Q&A to gain alignment and approval. Additionally, a deficiency that calls for more clinical data could result in an expensive study or the loss of product certification. With so much on the line, a different perspective and proposed response plan from our former notified body leaders and subject matter experts could make all the difference.
The RQM+ team will assess your CER process and documentation by product line, providing you with a detailed gap analysis and remediation plan. Our team of experts can effectively execute a remediation of any size, minimizing the burden on your team so you can maintain focus on new products.
Our CER project managers act as the single point of contact for all client needs and are responsible for leading meetings, developing schedules for deliverables, monitoring progress, and driving results. This includes actively managing the client approval process and coordinating independent review of all documentation.
For ongoing compliance, we ensure client documentation is updated as new data becomes available and then provided to notified bodies by the required deadlines.
Clinical evaluation preparation requires a deep understanding of medical devices, clinical data, and what is sufficient to prove safety, performance, and state of the art. RQM+ can take the lead so you do not have to.
Whether you need targeted support for specific tasks or comprehensive technical leadership and project management, RQM+ can help with every aspect of the clinical evaluation process.
Clinical evaluation is a continuous effort requiring integrated solutions. RQM+ is here as long as you need us.
We consistently meet reviewer expectations because we know what they want to see. Positive feedback from notified bodies proves it.
RQM+ leadership and staff includes people who have drafted MDCG guidance documents on clinical evaluation, device equivalence, and sufficient clinical evidence for legacy devices.
In MDCG 2020-6 guidance, it acknowledges that for a legacy device that's been on the market for a while, it's not appropriate to recreate the development plan because you've already been through that process. Instead, per the appendix to the guidance shows what you should have in lieu of having new clinical data, including a PMS plan.
From the NB point of view, you could write one CER that covers both the MDR and MDD requirements, and be clear so that the NB can see the delineation. This can be complicated to maintain, and require a lot of mapping and explaining, so it may be easier to separate the products.
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