Economic Operators FAQ
August 7, 2023
What does “Economic Operator” mean?
Who does it apply to? What are their responsibilities?
We answer these questions and more…
Category: FAQS
Conformity Assessment Procedures under MDR FAQ
August 7, 2023
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
August 7, 2023
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
August 7, 2023
What is Clinical Evaluation?
What guidance is there? What documents do you need?
We have the answers…
Clinical Evaluation Assessment Report FAQ
August 7, 2023
What is a Clinical Evaluation Assessment Report (CEAR)?
What is its purpose? Why do medical devices need one?
Read on to learn more…
Clinical Development FAQ
August 7, 2023
What is a Clinical Development Plan (CDP) under the EU MDR?
Why is it important? How does it differ?
We answer these questions and more…
Biocompatibility FAQ
August 7, 2023
What is biocompatibility for a medical device?
Why is it needed? What does it do?
We have all the answers and more…
510k vs MDR FAQ
August 7, 2023
What is the difference between FDA and EU MDR regulations for medical device approvals? How do they differ? What are the requirements?
We answer these questions and more…
