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MedTech

Developing a medical technology innovation is a challenging and complex process that requires knowledge, experience and resources. It is not enough to just have a good idea; you also need to be able to demonstrate that your product is safe, effective and user-friendly, and that it solves a real problem for your target group. You need to be able to navigate a rapidly changing, highly regulated and competitive market, where you can create value for your customers, partners and investors. Without the right support and guidance in the medical technology innovation process, you risk missing important steps and making mistakes that slow you down and give your competitors a head start.

As an independent research institute with extensive experience and expertise in medical technology, we have helped many customers develop medical technology products – from hearing implants and defibrillators to advanced cloud/edge services for sensors in smart patches. We have a large network of experts and partners who can contribute expertise, equipment and funding. In our advanced testing and development labs, you can get help evaluating, testing and validating your product under realistic conditions. We help you all the way from idea and concept to aftermarket.

Sara Bogren

Enhetschef
+46 70 915 18 08 Read more about Sara

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Services in MedTech
RISE offers services that support medical technology innovations all the way to market, from prototype development and biocompatibility testing to MDR certification and clinical studies. We can help you to navigate complex regulations and ensure that your products are safe and effective.

Why RISE

01

Innovation support throughout the entire process

– we support you from concept and prototype development through to MDR certification, clinical trials and post-market surveillance.
02

Test and validation lab

– advanced infrastructure for biocompatibility, sterilisation and performance testing in realistic conditions.
03

EU reference laboratory

– Performance testing and batch testing of high-risk IVD products for respiratory viruses in accordance with IVDR.
04

Regulatory expertise

– Support with quality management systems, technical documentation and navigating MDR/IVDR requirements.
05

Collaboration networks

– Gain access to cutting-edge medical expertise through Karolinska Institutet, Sahlgrenska University Hospital, and other leading research institutions.