Clinical Investigations: Yes, No, Which One?

How do I know whether I need a clinical investigation for my medical device?

Clinical investigations of medical devices can be a major hurdle for manufacturers, as they can be quite lengthy and expensive. Furthermore, the regulatory aspects are extensive and complex as well. Together with Curedatis, we  have created this free flowchart  which shows you when and whether a clinical investigation is necessary, and which regulations and requirements you need to comply with.



We'd like to point out that our web offer's sole objective is to provide information, without any guarantee of completeness. The information this is based on can change at any time.

About Curedatis

Curedatis is a startup that digitalizes and automates the clinical evidence process to help medical device, in vitro diagnostics, and digital health companies meet the requirements for sufficient clinical evidence under the EU MDR, IVDR, and DiGAV.

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About Climedo Health

Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.

By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation.

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