FREE Webinar – Performance Evaluation for In vitro Diagnostic Medical Devices

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 […]

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 […]

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 […]

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

FREE Webinar – Post Market Clinical Follow-Up

Join us for this free webinar: Post Market Clinical Follow-Up for a Medical Device – How to reach MDR Requirements? December 16, 2020  •  14.00-14.20 CET Learn more about how you can apply a post-market clinical follow-up in order to collect clinical data What is a post-market clinical follow-up (PMCF)? Examples of activities under PMCF How to […]

On-line GMP training with Mr. John Y. Lee

In times of Covid-19 restrictions we are working hard to adapt and to modify our courses for on-line streaming. For the first time can now offer courses with Mr. John Y. Lee on-line, live from USA: GMP Compliance Auditing December 1-4, 8.30-11.45 CET Practical and proven techniques for conducting effective audits of various pharmaceutical operations, […]