Placing medical devices on the market and keeping them there is now about much more than technical documentation and a quality system. The EU Medical Device Regulation (MDR) has shifted the emphasis strongly toward clinical evaluation. Manufacturers must continuously demonstrate that their device is safe, achieves its intended performance, delivers clinical benefit, and has an […]
Category: Product development and processes
Commercializing Health Technology: From Innovation to Market
The journey of health technology from innovation to market is a complex process that requires deep understanding of regulatory requirements, patient safety, and risk management. Product development in health technology differs significantly from other industries, as every stage from innovation to commercialization is strictly regulated and demands specialized expertise. Procurement organizations and manufacturers of health […]
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Clinical Evidence Requirements for Health Technology Products in the EU Market
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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How does the ManagiDiTH Winter School 2026 practically support companies’ innovation and RDI strategies?
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 […]
3 phases in front end innovation for health tech
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 […]
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