Clinical evidence for the EU market refers to scientific proof of a health technology product’s safety and efficacy in accordance with the MDR regulation. Requirements vary by device risk class and may include clinical investigations, literature reviews, or the use of existing real-world data. To obtain and maintain CE marking, manufacturers must demonstrate a sufficient […]
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ManagiDiTH – Master of Managing Digital Transformation in the Health Sector – is an EU co-funded education programme. The ManagiDiTH programme develops expertise isocietal impact, and digital skills in healthcare. In January 2026, a 5-day Winter School will be organised for the students, and we are currently seeking company partners for this event. The Winter […]
Does the following picture illustrate your innovation process? Unfortunately for a lot of companies it does. Journey of bringing a product idea to actual product release is a rollercoaster of enthusiasm and frustration (and occasional despair). There are some innovation rock stars who advocate complete freedom of ideation over processes. A star from the past […]
Read More… from 3 phases in front end innovation for health tech
The medical device field provides a fruitful ground for imaginative solutions that positively impact our health. However, producing an innovation is a complex journey, and when innovating medical devices, a variety of field specific characteristics and considerations are added to that journey. This blog discusses three points in terms of medical device innovation. 1. Aim […]
Read More… from Medical device innovation – a combination of imagination and safety
