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 »
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…
What is the purpose of an implant card?
When are they applicable?
What are the guidelines?
We have all the answers and more…
What is a Gap Assessment?
How can it help?
What does it involve?
Read on to learn more…
Why are ISO standards important for manufacturers?
What are Harmonised Standards?
How do you determine which are applicable?
We have all the answers and more…
What is Article 59?
What’s its purpose?
When is it appropriate to use it?
We answer these questions and 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 »
ISO standards help medical device manufacturers and the medical industry comply with the evolving ‘State of the Art’, international best practices, streamline processes, and improve patient safety and satisfaction. These standards improve risk management and help businesses fulfil legal and industry standards. There are numerous ISO standards in place, and Clin-r+ has constructed this paper to give you an overview of the most common standards for the MedTech industry.
The EU MDR’s regulations on clinical data ensures that the medical device being used on the general public for their treatment or diagnosis is safe. However, there is a category of devices, known as ‘orphan medical devices’, that may suffer if special consideration isn’t provided to it. CLIN-r+ looks at what they are and what this means.
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