Our expert team is laser-focused on telling a consistent story about your product. We do this by aligning study objectives and clinical outcomes from the clinical evidence report, adverse event questions and language from the instructions for use, and questions on new or emerging risks from PMS data. We create response scales that align with clinical practice and enable comparison of results to the risk management file and benefit-risk assessment.
When developing retrospective PMCF studies, we employ best practices and work closely with your team to gather inputs and perform a clinical evidence analysis from CERs, PMS data, and your risk management file. We provide guided ideation sessions to develop study questions, tailor them to clinical outcome measures, and create a custom response scale flowchart. The review process takes place in an online platform so every team member can provide input and work collaboratively.
As a strategic partner that always has your business goals in mind, we look for ways to add efficiencies across your portfolio and seek to identify areas of clinical data overlap in existing data, align end points of data to be collected, and bundle products in a single study or PMCF activity when possible.
At RQM+, we have already seen feedback on retrospective PMCF studies from notified bodies and are familiar with the expectations of notified bodies. With every project, we make process improvements based on lessons learned so you can be confident that we are applying the most current best practices to your studies.
When thinking about retrospective PMCF studies, it is a good idea to think about the clinical evidence, CER, history of the device from a post-market side as well to identify the areas of gaps and the areas where the device can be improved and then think through whether or not a survey would address those needs.
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