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.