Vi firar introduktionen av MDR tillsammans med Jesper Rönndahl

Den 26 maj träder det nya medicintekniska regelverker MDR (Medical Device Regulation) i kraft och det kommer att förändra vardagen för många medicintekniska aktörer. Kom och lyssna på när vår Åse Ek presenterar Jesper Rönndahl och hans tankar kring medicintekniska produkter i framtiden. Jesper Rönndahl känd från TV, radio och live uppträdanden – ståuppkomiker, programledare, […]

Inspirational Webinar – Your MDR Check list – now available on YouTube

On april 28th Key2Compliance® in collaboration with MVA (Medicon Valley Alliance) held an Inspirational Webinar – Your MDR Checklist. The recording of the presentation is now available on YouTube. Do you want to understand which parts of the MDR that you as medical device manufacturer must have in place on May 26th and what you […]

Biological and Clinical Evaluations for Medical Devices

Biological and Clinical Evaluations for Medical Devices

a Key2Compliance® Continued Development Conference – Malmö, Sweden October 5-6th The conference supersedes the previous conferences – Symbioteq Biocompatibility of Medical Devices – now organised by Key2Compliance®, a Symbioteq company. The conference has a new format which we hope will suit your medical device needs and is designed to be valuable for both specialists and […]

IVD Performance Evaluation Webinar recording now available

Follow up on free Webinar from March 24th – Performance Evaluation for IVD Medical Devices – How to Reach IVDR Requirements? Maybe not all that registered to attend the live session had the opportunity to take part for one reason or another, so we have made the recording available on our website for you to […]

IEC 62304 Webinar recording now available on web site

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 […]