Sustainability is a pressing matter that medical device developers and manufacturers need to embrace, but it is not straightforward. This paper looks at where we are now, and what it means for manufacturers and the design of their medical devices.
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+ wants to assist manufacturers to understand the state of the art and provides guidance to help explain what it is and how it can help make your CE submission successful.
Clin-r+ outlines the requirements and considerations manufacturers should review to ensure that Clinical Investigations they undertake are well researched to ensure a return on investment.
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.
Manufacturers can circumvent the time and expense of conducting clinical studies to satisfy the safety and performance requirements as outlined in the clinical evaluation by claiming equivalence with another device to get CE certification under the MDR.
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.
MEDDEV 2.7/1 Rev 4 is a Clinical Evaluation guide for manufacturers and notified bodies and the MDR provides further information on the clinical data requirements. CLIN-r+ explains the key stages of clinical evaluation and what documentation you need.
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.
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