Innovation support for medical device development
The market for medical devices is globally one of the most highly regulated and technologically advanced industrial sectors. For a product to be sold within the EU, it must comply with the Medical Device Regulation (MDR), including requirements for CE marking, technical documentation, clinical evaluation, risk management and traceability throughout the product lifecycle.
This makes the development process complex and resource-intensive, particularly for innovative solutions involving advanced technologies such as smart sensors and AI-based functionality. At the same time, the sector faces strong competition, rapid technological development and increasing demands for quality and safety from both regulators and users, placing high demands on product development and regulatory strategy.
We support companies throughout the entire development journey — from idea and concept to a verified and regulatory-ready product. Get in touch and we will help you move your project forward.
Support throughout the medical device development journey
Throughout the entire lifecycle of a medical device, we offer expertise and technical infrastructure for development, verification and regulatory work in accordance with MDR. We support you from idea and concept to CE marking and post-market support.
Contact us for a free consultation
Services in medtech
Solution
Early-stage medical device idea and concept development
Do you have an idea for a medical device? Then it is important to consider key factors early in the development process, including MDR requirements, risk management, intellectual property (IP) and technical feasibility. The right support in the idea and concept phase can save time and reduce the risk of costly detours later in development. Discover how we can support your medical device idea from the very start.
Solution
Medical device product development
Once a concept has been defined, development moves forward to design, prototyping and testing. During the product development phase, medical devices must be developed, evaluated and documented in accordance with the requirements of the Medical Device Regulation (MDR). Explore how we can support your medical device product development.
Solution
Post-market support for medical devices
Medical devices must be monitored even after they are placed on the market. Regulations such as the Medical Device Regulation (MDR) place increasing demands on systematic post-market surveillance, data collection and clinical follow-up through Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF). At the same time, manufacturers need to manage deviations, product changes and regulatory updates. Explore how we can support your post-market activities.
Service
EU reference laboratories
RISE is one of five EU reference laboratories in Europe for high-risk medical products for in vitro diagnostics (IVD).
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Selected services for testing and biological evaluation of medical devices
Service
ISO 17664 Validating Instruction for Users - cleaning and disinfection
For reusable medical devices, there must be a validated Instruction for Users (IFU) for cleaning and disinfection. We assist in creating a functional instruction according to both ISO 17664-1 and ISO 17664-2 and validate that the products are properly cleaned and disinfected.
Service
ISO 17665 Validation of Sterilization Instructions
In the Instruction for Users (IFU), supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to EN ISO 17665:2024.
Service
ISO 10993-5 Cytotoxicity Test - in vitro
Cytotoxicity testing is a crucial part of the biological evaluation of medical devices and is a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts cytotoxicity testing according to ISO 10993-5 and is accredited under ISO/IEC 17025 or GLP (Good Laboratory P…
Service
ISO 10993-23 Skin Irritation - in vitro
Irritation testing is a critical component of the biological evaluation of medical devices and a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts irritation tests according to ISO 10993-23 and adheres to Good Laboratory Practice (GLP).
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.Relevant areas for you
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