Medical Device Design FAQ
What are the EU MDR requirements for device design?
How does it affect your QMS? What changes are needed?
Read on to learn more…
FAQS
MDD vs MDR FAQ
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
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
What is EUDAMED?
What’s its purpose? What information does it store and how?
Read on to learn more…
Economic Operators FAQ
What does “Economic Operator” mean?
Who does it apply to? What are their responsibilities?
We answer these questions and more…
