IVDR – Literature searches as part of Performance Evaluations

Within a year, IVDR will enter into force and one of the new requirements is performance evaluation of your IVD product, among other things. Johanna Fugelstad and Katalin Holenyi will talk about this and more during a free Webinar on March 24. Do not miss the opportunity – sign up here  Free Webinar on Performance […]

Are your PMCF plan ready for MDR on May 26th?

Do you know that on May 26th this year your medical device company need to have a plan in place for Post-Market-Clinical- Follow-up for every device or device family to comply with MDR?  

Anna Lundén speaking for IDA about Life Science Auditing

The Danish Society of Engineeers – IDA – has invited Anna Lundén from Key2Compliance® to speak on their continues knowledge upgrade program – IDA Upgrades. The topic today is – Life Science Auditing – challenges and possibilities. The session has attrackted some 90 interested IDA members and Anna will amongst other things touch the subjets […]

LMV informerar om kliniska prövningar relaterat till MDR

Hur vet jag om en studie är en klinisk prövning av medicinteknisk produkt? Läkemedelsverket har tagit fram en film för att förtydliga vilka kliniska studier som omfattas av bestämmelserna i det nya regelverket om medicintekniska produkter.

Welcome Mia Rinde to our Clinical Development team

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.

Welcome Marcus Mellin to our Regulatory Affairs team

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 […]

Brexit och medicintekniska produkter

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 →

Welcome to Barbara Musi

Barbara brings 25 years of experience as senior specialist in global support for biocompatibility strategy and toxicological risk assessment of products in development and sustaining products for dialysis systems and intensive care units at Baxter (previously Gambro AB), Lund Sweden. Most recently she worked for Altran as senior consultant toxicology and biocompatibility supporting MDR compliance. […]

Welcome to Andrea Björkman

Andrea will strengthen our growing consultancy services with focus on area Clinical Development. Andrea comes from an assignment as project manager at the Department of Medical Biochemistry and Biophysics, Karolinska Institutet at SciLifeLab. She has a strong knowledge in research methodology from studies in cancer biology and the cell’s response to genotoxic stress to maintain […]

Welcome to Terese Wasell

Terese Wasell joins Key2Compliance Regulatory Affairs team as senior consultant and she brings over 15 years of experience in regulatory affairs, 5 years in post market surveillance and complaint handling and also quality and compliance experience. Most recently she came from Roche Diagnostics Scandinavia AB and she have had previous positions at Olerup SSP AB/CareDx […]