Clinical investigations, commonly referred to as clinical trials, play a pivotal role both in developing new treatments and in detecting, diagnosing,
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
MedTech, or medical technology, is every product, service, or solution using medical technology to improve peopleβs health by preventing, diagnosing,
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity
Many medical device companies think they are ready to conduct clinical investigation studies when they are actually months away from initiating a
Checkout our selection of resources about medical devices and clinical writing.
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