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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.

Sara Bogren

Enhetschef
+46 70 915 18 08 Read more about Sara

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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.

Medicinteknisk utveckling, från idé till CE-märkning med rätt stöd

RISE kombinerar teknisk infrastruktur, expertis och regulatorisk kompetens under ett tak. Vi stöttar medicintekniska företag genom hela utvecklingsprocessen, från tidig konceptutveckling och MDR-anpassad produktutveckling till eftermarknadsstöd.

Solution

Early-stage medical device idea and concept development

Do you have an idea for a medical device? Already at the concept stage you need to consider MDR requirements, risks, IP and technical feasibility. With the right support from the beginning, you save time and reduce the risk of costly detours. Discover how we can help you develop your idea.
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 have been launched on the market. Regulations such as the MDR impose increased requirements for systematic post-market monitoring, data collection and clinical follow-up through PMS and PMCF. At the same time, manufacturers must manage deviations, product changes and regulatory updates. Explore how we can support your post-market activities.
Selected services for the testing and biological evaluation of medical devices
In order for a medical device to be CE marked, it must meet the requirements for biological safety, cleaning, and sterilization as specified in the MDR and relevant ISO standards. We offer testing, validation, and analysis services to help you verify safety and performance prior to market authorization.

Contact us for a free consultation and quote.
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 Practice).
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).
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.

Följ Life Science at RISE

Få insikter om forskning, innovation och lösningar inom life science – från tidig utveckling till implementering i praktiken.
Följ vår LinkedIn-sida
Kundberättelser
Att få en medicinteknisk produkt att fungera i verkligheten är sällan rakt på sak. Här kan du utforska hur det görs i praktiken. Från nya instrument som gör ingrepp snabbare och möjliggör behandling samma dag, till individanpassade blodkärl som utvecklas för transplantation och nu förbereds för kliniska studier. Läs hur andra har tagit sig från idé till verifierade resultat.
Artikel

Individualiserade organ ska testas på patienter

Det finns ett stort intresse globalt för ATMP, Advanced Therapy Medicinal Products. Det handlar om regenerativmedicin, det vill säga cellterapi, genterapi och vävnadsterapi som alla bygger upp eller ersätter organ i kroppen. RISE har under många år samarbetat med biotech-bolaget VERIGRAFT, det handlar om en ny metod för att individanpassa blodkärl för transplantation av vener med klaffar.
Artikel

Svensk uppfinning revolutionerar behandling av urinblåsecancer

Urinblåsecancer är en av de vanligaste cancerformerna i världen och drabbar långt över en halv miljon människor årligen. Behandlingen är både komplicerad och kostsam, och innebär att patienten behöver stanna kvar på sjukhus i dagar efter en operation. Det svenska företaget Multi4 vill ändra på detta. Med deras egenutvecklade multiverktyg kan ingreppet göras betydligt snabbare, och patienten kan gå hem redan samma dag.
Artikel

Återvunnet material ska ta plats inom sjukvården

Ungefär en femtedel av alla klimatpåverkande utsläpp från offentlig sektor kommer från hälso- och sjukvården. Regionernas åtgärder: Förändra användningen av förbrukningsmaterial och oftare använda förnybara, återvunna eller cirkulära material.   Nu genomförs flera projekt för att kunna göra den ambitionen möjlig – och visa fler producenter att det går att gå över till återvunnet. 
Safe and sustainable development of hygiene and medical devices
A unique combination of materials science and medical technology expertise enables the interdisciplinary development and validation of absorbent, textile-based, and hygienic products for healthcare. With expertise in functionality, biocompatibility, chemical safety, and life-cycle considerations, we ensure effective, safe, and sustainable solutions.
Expertise

Evaluation of functionality and safety in absorbent materials

There is increasing interest in treated textiles and absorbent materials in products such as wound care, menstrual and incontinence products. By treating the textiles, you can prevent infection, unwanted odors and/or enable longer use or reuse. But how can you be sure that your products meet requirements and expectations?
Expertise

Sustainability in healthcare products

The healthcare sector accounts for 4.4% of global greenhouse gas emissions. If it was a country, it would be among the five largest emitters. When there is a need to develop sustainable products and packaging for healthcare, RISE supports with expertise and tests that ensure both functionality and safety – from early prototype to finished solution.
Service

Test methods for wound dressings SS-EN 13726:2023

There are different types of dressings with specific properties. Dressings can be used to manage wound fluid, create an optimal wound environment and protect wounds against external influences such as bacteria and viruses. 
Projects driving the development of a sustainable medical technology industry
The medical technology industry is facing an increasing sustainability challenge. The use of single-use products and complex material combinations, as well as strict hygiene and safety requirements, leads to large waste streams and a significant environmental impact. At the same time, innovation must occur without compromising patient safety or regulatory requirements.

Read on to find out about some of the projects driving the shift towards a more circular, resource-efficient and sustainable medical technology industry, from material selection and design to recycling and new business models.
Project

Development of bio-based, sustainable MedTech disposable product

The project explored the potential to develop a bio-based disposable medical device with low environmental impact. It involved identifying more sustainable materials for products intended for short-term use inside the body.
Project

ReNoWo 2

There is extensive use of single‑use products in healthcare, both non‑woven and plastic, which today are sent for incineration with energy recovery. The project will investigate how to create an infrastructure that directs the material to recycling instead, which strengthens supply security and reduces climate impact.
Biotechnology / Expertise

Blue biotechnology

The blue economy side streams (fisheries, aquaculture) are generating considerable biomasses that are wasted or at best used for low value products. This is unfortunate as the biomass (fish, crustaceans, algae) is rich in precious bioactive components. At RISE, we valorize these renewable components into high value products.

Why RISE

01

Innovation support throughout the entire process of developing medical devices

– From concept and prototype development to MDR certification, clinical trials, and post-market surveillance.
02

Advanced technical infrastructure for development, testing, and verification

– With state-of-the-art laboratory equipment, accredited methods, and custom-designed test environments, we offer a robust technical infrastructure for medical device development. We conduct testing in accordance with ISO standards, as well as simulations and validations that ensure functionality, biological safety, and regulatory compliance—from early prototypes to the finished product.
03

EU Reference Laboratory for IVD Products

– As an EU Reference Laboratory (EURL), we play a special role in the evaluation of high-risk in vitro diagnostic devices under the IVDR. We conduct independent performance testing and batch verification of Class D products, such as tests for respiratory viruses. Our mission is to ensure that diagnostic tests meet the EU’s highest standards for quality, safety, and reliability.
04

Regulatory expertise

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

Collaborative networks

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

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