Holiday educational series a joint initiative of MDR Regulator and Pure Clinical

A simple and accessible format. Clear, understandable language – this is how MDR Regulator’s experts explain even the most complicated issues concerning the medical device industry.

With medical device manufacturers and their clients in mind, MDR Regulator together with Pure Clinical have prepared a special educational series, in which experts from both companies explain, among other things, what requirements a medical device manufacturer should meet in order to market a device on the European Union market, who the person responsible for regulatory compliance is and what qualifications he or she must have, and whether a biological assessment should be conducted for each medical device, as well as how to conduct a biological assessment of a device.

As part of the series, specialists also explain what a feasibility assessment of a clinical trial of medical devices and in vitro diagnostic medical devices consists of. One of the episodes is devoted to explaining the conditions that need to be met in order to start a performance test in accordance with IVDR. Among other things, one can learn how to prepare the necessary documentation and what should be included in the application form, the investigator’s brochure and the action research plan.

MDR Regulator offers a full range of services enabling medical device manufacturers to place their products on European markets and ensuring continuity and compliance of their operations with applicable European laws.

A company can use MDR Regulator’s services at any stage of product launch – from design, through implementation, testing, documentation, certification, registration or notification, and post-market services (distribution, marketing, market surveillance and other activities).

Pure Clinical, on the other hand, offers professional clinical testing services for medical devices and in vitro diagnostic medical devices for the medical industry.

We encourage you to get in touch and follow our profile on LinkedIn, Facebook and Instagram, where we publish the latest episode of our vlog every Monday.