MedTech & IVD

RISE offers unique and broad competence within the medical technology and in vitro diagnostic innovation chain. With us, you get support throughout the entire development process, or for specific point efforts where the right network, skills or equipment are missing. Together, we discover and prevent problems along the innovation journey – from idea to market introduction and after-market control. Expertise within e.g.:

Preclinical safety and functionality evaluation in vitro and in vivo; biocompatibility according to ISO10993; physical, chemical and microbiological characterization; software (IEC62304); stability; clinical evaluation; performance testing; MDR and IVDR expertise and guidance; risk management; usability; technical documentation; validation of cleaning, disinfection, and sterilisation; packaging.