Technical Documentation FAQ
Are there any guidelines for the structure of the Technical Documentation?
What should be in each section? What do Notified Bodies expect to see?
We have all the answers…
FAQ
Summary of Safety and Clinical Performance FAQ
What is the Summary of Safety and Clinical Performance (SSCP)?
Does it apply to your device? Where can you find guidance?
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State Of The Art FAQ
What does “state of the art” mean in the context of medical devices?
Why is it important? What do you need to do?
We answer these questions and more…
Risk Management FAQ
Why do manufacturers need Risk Management?
How is it defined for medical devices? What ISO is applicable?
We have all the answers…
Post Market Surveillance FAQ
What is Post Market Surveillance (PMS)?
What’s it used for? Why do you need it?
We have all the answers and more…
Post Market Clinical Follow up FAQ
What is Post Market Clinical Follow-up (PMCF)?
What is the point? What do you need to be compliant?
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Conformity Assessment Procedures under MDR FAQ
What is the process for demonstrating conformity of devices?
How does this differ depending on device class?
We have the answers and more…
Clinical Investigation FAQ
What are clinical investigations according to the EU MDR?
Why is clinical data required? What types of clinical investigation can be conducted?
We have all the answers and more…
Clinical Evaluation FAQ
What is Clinical Evaluation?
What guidance is there? What documents do you need?
We have the answers…
Clinical Evaluation Assessment Report FAQ
What is a Clinical Evaluation Assessment Report (CEAR)?
What is its purpose? Why do medical devices need one?
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