A Medical Device Quality Management System (QMS) is a set of policies, processes, and procedures that a medical device manufacturer uses to ensure that their products are safe and effective for their intended use. CLIN-r+ explains what it is, and why it’s so important for manufacturers.
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…
This case study looks at supporting an MDD to MDR transition and how CLIN-r+ supported one manufacturer when they decided on outsourcing EU MDR to allow internal resources to remain focussed on New Product Introduction (NPI).
This case study looks at supporting an FDA 510k to MDR transition and how CLIN-r+ supported one manufacturer’s journey to enter the European market by leveraging their FDA 510k certificate.
The CE mark is a major milestone for most medical devices. It can take a long time to obtain and be a challenging process. CLIN-r+ looks at the manufacturer responsibilities once the CE mark has been granted, update requirements, and more.
Clin-r+ Ltd can assist medical device manufacturers with gap assessments and the transition to MDR. An EU MDR Readiness checklist can assist in efficient planning. It should be a practical tool that ensures you are compliant with the regulations.
Clin-r+ sets out what you need to know to place a medical device on the market in Great Britain, Northern Ireland, and the EU. In this paper, we set out what you need to know and highlight the differences depending on where you’re based and which market(s) you sell on.
Intended Purpose, Intended Use and Indications for Use are all terms that are often confused. Not only do they sound similar, but their definitions in relation to a device can be easy to mix up. Clin-r+ explains what they actually mean.
Starting an EU MDR gap analysis of your FDA 510K submission early on will speed up your progress in both the US and EU markets. FDA and MDR definitions differ. Clin-r+ advises on how they compare.
How does your MDD submission translate to the MDR? Clin-r+ examines the main distinctions and what they imply for submissions made before the deadline.
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