EU MDR requires manufacturers to provide “implant cards” for patients with implanted medical devices. The intention is to make crucial information about implants easily accessible to patients. CLIN-r+ explains what manufacturers are responsible for.
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?
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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).
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.
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