Pre-Clinical and Clinical Affairs Consulting
BioVision supports all of your pre-CE clinical studies and Post-Market Clinical
Follow-up (PMCF) challenges. Together we secure sufficient clinical evidence to satisfy regulators and demonstrate that your device is safe and performs as intended.
Clinical evidence is now a central requirement
Under the EU MDR especially, clinical evidence expectations have risen sharply. Manufacturers must demonstrate clinical benefit through a robust Clinical Evaluation Report (CER) and maintain evidence after launch through PMCF.
How BioVision helps
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It identifies the specific regulatory requirements that must be addressed.
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It connects to the risk management activities and plan.
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It is relevant to the clinical claims that are being made.
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It verifies the need to collect (additional) clinical data.
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It addresses the relevant clinical research questions.
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a structured assessment of clinical data demonstrating that a device meets safety and performance requirements. It is mandatory for CE marking under the MDR.
What is PMCF?
Post-Market Clinical Follow-up is the continuous collection of clinical data after a device is on the market, to confirm ongoing safety and performance. The MDR requires it for most devices.