State Of The Art FAQ
August 7, 2023
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…
Category: FAQS
Risk Management FAQ
August 7, 2023
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
August 7, 2023
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
August 7, 2023
What is Post Market Clinical Follow-up (PMCF)?
What is the point? What do you need to be compliant?
Read on to learn more…
Person Responsible for Regulatory Compliance FAQ
August 7, 2023
What is a Person Responsible for Regulatory Compliance (PRRC)?
Who needs one? Who can be one? What do they do?
We answer these questions and more…
Periodic Safety Update Report FAQ
August 7, 2023
What is a Periodic Safety Update Report (PSUR)?
Which devices require one? What are the requirements?
We have the answers and more…
Medical Device Design FAQ
August 7, 2023
What are the EU MDR requirements for device design?
How does it affect your QMS? What changes are needed?
Read on to learn more…
MDD vs MDR FAQ
August 7, 2023
What is the difference between the Medical Device Directive (MDD) and the Medical Device Regulation (MDR)?
What are the main changes? When do you need to be compliant by?
We answer these questions and more…
Instructions For Use and Labelling FAQ
August 7, 2023
What is the purpose of Instructions for Use (IFU)?
What does it need to include?
How do you create MDR compliant labels?
We have all the answers…
EUDAMED FAQ
August 7, 2023
What is EUDAMED?
What’s its purpose? What information does it store and how?
Read on to learn more…
