Mia Rinde joins the clinical development team as a medical writer and information specialist working primarily with clinical evaluations. She is into systematic literature reviews and has a passion for detail. Mia holds a licentiate degree in physiology from Stockholm University where she performed preclinical studies on a prospective medical device targeting diabetes.
FREE Webinar – Performance Evaluation for In vitro Diagnostic Medical Devices – How to reach IVDR Requirements? March 24, 2021 Learn more about how to perform a Performance Evaluation for IVD products. Course outline What is a Performance evaluation (PE)? Key aspects of PE including Scientific validity, Analytical performance and Clinical performance Examples of activities […]
Marcus Mellin joins the Regulatory Affairs team with focus on risk management as well as expertise on electrical medical equipment. Marcus has for the last 7 years been at Intertek Semko, most recently as Business Unit Manager of the Medical Testing department but has previously also performed testing of products in accordance with both the […]
Från och med 1 januari 2021 är Storbritannien ett tredje land i förhållande till unionen (EU/EES). Det medför nya villkor för handel med medicintekniska produkter mellan Storbritannien och unionen och innebär också att en tillverkare inte kan ha en auktoriserad representant eller anmält organ i Storbritannien utanför Nordirland. Länk till Läkemedelsverket →
Follow up on free IEC 62304 Webinar from January 25th – Medical Device software life cycle processes – IEC 62304 an overview. We realized that everyone who registered or showed interest did not have the opportunity to attend or missed parts of the Webinar, for one reason or another, so we have made the recording […]
Follow up on free PMCF Webinar from December 16th – Post Market Clinical Follow-Up for a Medical Device – How to reach MDR Requirements? We realized that everyone who registered or showed interest did not have the opportunity to attend or missed parts of the Webinar, for one reason or another, so we have made […]