Our powerhouse team includes former notified body leaders, regulatory experts, medical doctors, clinicians, statisticians, and IVD technology experts, covering every class of IVD.
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 related 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.
We've seen some manufacturers struggling to define what analytical and clinical parameters are for their IVDs. What is the notified body's expectations on this? Hear the answer from RQM+ Vice President of IVD Intelligence and Innovation, Carlos Galamba.
Our finely honed processes and tools ensure a cohesive story of sufficient clinical evidence throughout your technical documentation. The PER, PMS, PMPF, risk file, and IFU must all be singing in harmony, providing the notified body reviewer with confidence in your evidence and path forward.
Our processes incorporate multiple checkpoints to ensure alignment and quality control checks to verify accuracy. We also provide routine maintenance so you never miss a deadline, and ongoing updates so that your PERs are always audit-ready.
We create a clear mapping between the intended purpose and evidence for demonstration of clinical conformity via a performance 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/PMPF 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 customized 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 PERs.
On the subject of clinical evidence, are manufacturers required to demonstrate clinical utility under the IVDR? Listen to RQM+ Vice President of IVD Intelligence and Innovation, Carlos Galamba's, answer.
Our experts will help you develop a performance evaluation strategy to achieve your business objectives and notified body approval.
We provide innovative strategies based upon our experience with a wide range of notified bodies.
From PEPs to SSPs, 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.
PERs 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 IVDR now and in the future.
The notified body may not interpret the IVDR 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 PER 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.
Performance evaluation requires a deep understanding of IVDs. RQM+ can take the lead on writing your performance evaluation report so you can focus on what you do best.
Whether you need targeted support for specific tasks or comprehensive technical leadership and project management, RQM+ can help with every aspect of the performance evaluation process.
Performance evaluation is a continuous effort and integrated systems. RQM+ provides all the support you need.
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 performance evaluation, device equivalence, and sufficient performance evidence for legacy devices.
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