Systematic Literature Review (SLR) FAQ
Why do you need a systematic literature review?
What steps are involved?
What are some key reasons for non-conformances in literature reviews during audits?
We have the answers to these questions and more…
Technical Documentation
Quality Management System (QMS) FAQ
What is a Quality Management System (QMS)?
Why is it important?
How does it work?
We have the answers to the questions and more…
Claiming Equivalence FAQ
What is the difference between claiming equivalence under EU MDR compared to MDD?
What are the key requirements for demonstrating equivalence?
What can improve the process of demonstrating equivalence under the EU MDR?
We answers your questions and more…
Post CE mark FAQ
What do you need to do after obtaining a CE mark?
What is involved in updating Technical Documentation post-CE mark?
We answer these questions and more…
Top MDR Submission Feedback
Feedback from MDR regulatory submissions are valuable assets that we incorporate in our EU MDR transition projects and strategy documents for clients. CLIN-r+ shares the evolving collective expert knowledge to support you in your MDR submissions.
Biocompatibility
Recent changes to ISO 10993-1 have changed the landscape of medical device biological safety testing. The toxicity test box ticking from the biocompatibility test matrix is no longer used. Materials analysis, chemical risk analysis, analytical chemistry, and toxicological risk analysis have all been introduced. Clin-r+ explains what you need to know.
Clinical Regulatory Affairs – Consultancies vs Agencies
Consultancies vs agencies – they’re all the same, right? Actually, no. There are quite big differences between the two, and some of them might be surprising. We provide a comparison to ensure that manufacturers can make informed decisions about who they work with and why.
Clinical Regulatory Affairs – Consultancies vs Agencies Read More »
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…
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…
