Services in MedTech

Active substances are found in a wide range of products, from antimicrobial agents in wound care to nutrients in food. By encapsulating these substances in microscopic reservoirs, it is possible to both protect them from chemical degradation and control their release over time.

Solution blowing is a manufacturing process used to produce nonwoven materials from polymers in solution. The solution is pumped through a spinneret, where high-velocity air is blown concentrically along each spun filament, which is stretched and collected on a drum or in a bath to form a nonwoven …

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…

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).

ISO 13485 is a harmonized standard used to meet the regulatory and legislative requirements necessary to provide medical devices and associated services in Europe.

The European Commission has designated 5 different labs in Europe to become EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.RISE has been designated in the scope "Respiratory viruses that cause life-thre…

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. 

The majority of medical devices used today contain software in some form. This in turn places various requirements on the software, regulated in standard IEC 62304. RISE can assist in evaluating that the requirements of this standard are met. 

Validation of ABO, RH, Duffy and Kell blood group analyzes prior to IVDR approval.

RISE offer in vitro-analyses to study interactions between material/subtances and cell lines.

Would you like to know more about the 3D-structure of your material on the micro- to centimeter scale? Would you like to peek into the inside of your product without destroying it or taking it apart? We offer non-destructive imaging through our lab-based X-ray microscope in 2D, 3D (tomography) and …

Testing of products and devices according to EN 149, EN-ISO 20743, EN 14683, EN 1500,EN 1499, EN 166 and EN ISO 18526-3.

RISE offers in vitro analysis to study interactions between the small intestine and substances or microbiota.

All medical devices have to undergo a biological evaluation of biocompatibility to fulfill the requirements in the EU Medical Device Regulation (MDR). We can help you with everything from setting up a biological safety evaluation plan according to ISO 10993 and ISO 14971 to performing the required …

The National Laboratory for Length and Dimensional Metrology offers calibration of line scales.

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.