Non Conformances FAQ
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…
FAQS
Implant Cards FAQ
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
What is a Gap Assessment?
How can it help?
What does it involve?
Read on to learn more…
Common Standards FAQ
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
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and more…
Sustainability FAQ
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
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
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…
Person Responsible for Regulatory Compliance FAQ
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…
Person Responsible for Regulatory Compliance FAQ Read More »
Periodic Safety Update Report FAQ
What is a Periodic Safety Update Report (PSUR)?
Which devices require one? What are the requirements?
We have the answers and more…
