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 […]

PMCF Webinar recording now available on web site

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 […]

FREE Webinar – An overview of IEC 62304 Medical Device software

Join us for this free webinar January 25, 2021  •  14.00-14.20 CET Learn more about how you can comply with the IEC 62304 standard in your Medical Device software development and maintenance process. When to apply IEC 62304? Overall development process for a medical device that is or includes Software Main points of IEC 62304 How to […]

Free BSI Webinar – UKCA for Medical devices and IVDs, are you ready?

Free live webinar Join BSI’s Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, to hear the latest updates on Brexit and the new UK Conformity Assessed mark (UKCA) for medical devices. More information: https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/ Register: Tuesday, 12 January, 2021 9:00 – 10:00 GMT Tuesday, 12 January, 2021 16:00 – 17:00 GMT