Non Conformances FAQ
October 12, 2023
What is a Non Conformance?
What is CAPA?
How should non-conformity procedures and processes be set up?
We have all the answers and more…
Category: FAQS
Implant Cards FAQ
October 12, 2023
What is the purpose of an implant card?
When are they applicable?
What are the guidelines?
We have all the answers and more…
Gap Assessment FAQ
October 12, 2023
What is a Gap Assessment?
How can it help?
What does it involve?
Read on to learn more…
Common Standards FAQ
October 12, 2023
Why are ISO standards important for manufacturers?
What are Harmonised Standards?
How do you determine which are applicable?
We have all the answers and more…
Article 59 (EU MDR) and CE Marking FAQ
October 12, 2023
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and more…
Sustainability FAQ
August 21, 2023
Why is sustainability important in medical device development and manufacturing?
What impact does it have? What is important to consider?
Read for the answers…
Unique Device Identification FAQ
August 7, 2023
What is UDI or Unique Device Identification?
What is its purpose in Europe? Where can you get one?
We answer these questions and more…
UKCA FAQ
August 7, 2023
What is the UKCA?
Who is it applicable to?
When can the CE mark be used in Great Britain until?
We have all the answers and more…
Technical Documentation FAQ
August 7, 2023
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…
Summary of Safety and Clinical Performance FAQ
August 7, 2023
What is the Summary of Safety and Clinical Performance (SSCP)?
Does it apply to your device? Where can you find guidance?
Read on to learn more…
