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.
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.
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 (NCs) and non-conformance reports (NCRs) are important for medical device manufacturers to understand and manage correctly. CLIN-r+ highlights the key information that manufacturers need to know.
The Toxicological Risk Assessment and Biological Evaluation documentation will undergo significant modifications with the release of the much awaited revisions in this area. Clin-r+ highlights the changes made in 2023 to toxicology and biological evaluation that manufacturers need to be aware of, and what it means for the documentation required to be compliant.
Toxicological Risk Assessment and Biological Evaluation Read More »
An MDR gap assessment is the process of looking at a medical device’s technical file in a systematic way to determine if it meets all of the relevant MDR requirements. It is the first and most important step in understanding what needs to be done for a device to become MDR compliant. CLIN-r+ shows how a gap assessment can quickly identify important information.
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