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The age of paper has passed and eConsent is becoming an increasingly popular method to obtain informed consent in clinical investigations. The benefits of using eConsent in clinical investigations become clear to many companies as they replace outdated paper-processes.
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With the date of application for the MDR approaching fast, many are struggling to design a PMCF plan to pass the scrutiny of Notified Bodies. Because of the lack of guidance and experience on PMCF, determining design choices of a PMCF study, such as the sample size, can be a challenge.
To maximise resources and overcome new challenges brought on by the new MDR and IVDR requirements, clinical teams need to eliminate typical issues that can hinder a successful transition towards compliance.
A PMCF survey under the MDR is not like a traditional survey. As a sponsor, you need to ensure that the methods and data will pass the scrutiny of the Notified Bodies.
This live Q&A provides MedTech industry professionals with a chance to get actionable insights by getting their own questions answered and also derive inspiration from the questions asked by their peers.
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When developing medical devices, companies are prone to fixate on obtaining the obligatory CE mark or FDA approval. Many fail to identify the need to strategically plan their journey during the development lifecycle towards market access success
One of the first crucial steps in designing a clinical study is determining the number of subjects to recruit i.e the study sample size. To pass scrutiny from Notified Bodies on PMCF and clinical investigation plans, you have to justify sample size estimation with scientific reasoning. Even though the webinar will present statistical methods they will be explained in a simple and relatable way.
Planning and executing a successful post-market clinical data collection strategy is a challenge, and the lack of examples of how PMCF studies shall be conducted leaves many uneasy. The requirements for clinical evidence vary depending on the device type and classification, but “proactive” remains a keyword within the regulation.
The MDR is very clear on what a PMCF plan should include, but the choice of strategy can greatly vary from one device to another. If you are looking for guidance on your choice of strategy for your medical device PMCF plan, this webinar is for you.
