This 23-page White Paper summarises the MDR and makes its contents easy to digest. It is intended to highlight those areas in the text that are most relevant to medical device manufacturers.
Download our exclusive regulatory guidance documents
Mastering the MDR White Paper
PMS in the MDR White Paper
The MDR places a higher burden on manufacturers in many areas including Post-Market Surveillance system design, implementation and reporting. This 12-page White Paper offers guidance on the requirements for PMS in the MDR.
Software as a Medical Device White Paper
Understand when and why the MDR applies to medical software, a rapidly growing sector of the medical device market. Learn whether or not the MDR will apply to your software medical device and how to work with the new legislation.
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EnableCE: Your EU MDR Strategy Toolkit
Do it once and do it right with our training courses and fill-in-yourself templates. Gain confidence, reassurance & control over your EU MDR strategy.