Speaker announcement: Judith de Wilde from Axon Lawyers

Make compliance your success factor – a conference for QA/RA professionals We are delighted to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund: Judith de Wilde, Attorney at Law at Axon Lawyers Judith will deliver two presentations at the conference:  Interaction between manufacturers […]

First speaker announced – Medical Device Product Life Cycle Conference

Make compliance your success factor –  a conference for QA/RA professionals We are delighted to introduce the first speaker Cyrille Michaud at our upcoming conference on the 26-27th of Ocotober in Lund, Sweden. The title of Cyrille’s presentation is “Device Software and Change control – how can SW manufacturers manage changes under MDR?”  Short introduction […]

Vitalis 2022 – Join our presentation on the 17th of May

Are you a manufacturer of a medical device software and curious to know more about clinical evaluation? Then you should visit Scandinavia’s largest eHealth event, Vitalis 2022, next week and listen to Johanna Fugelstad presentation. She will talk about clinical evaluations and highlight some basic and important concepts of the process. Date: 17th of May Time: […]

MVA Boost Seminar – From idea to success

–  Join our Boost Seminar together with Medicon Valley Alliance in Copenhagen There are a large number of new start-ups in Medical Device and In Vitro Diagnostics in the Medicon Valley area. This seminar will focus on how a start-up in Medical Device or In Vitro Diagnostic can accelerate the development from idea to success […]

Free webinar: Application for Clinical Investigations

How to prepare your submission package Learn from our experienced clinical development consultants which documents are required, what to consider and how to avoid delays. In this session, you will an overview on the documents and process required. It is teaser for the upcoming Key2Compliance training/course on Medical Device Clinical Investigations in May. Which documents […]

Free webinar: Is your medical device software MDR ready?

There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]

FREE Webinar! Mastering the regulatory maze – Introducing Gate2GMP®

20 min free webinar In the 20-minute top-level webinar we will demonstrate an easier way to find relevant regulatory guidance using our unique document library and database Gate2GMP®: Mapping the fragmented landscape of GMP-guidance Explaining why using Gate2GMP® will help you find the right guidance faster, much faster! Case study: Answering difficult QA/GMP-questions with Gate2GMP® […]

FREE Webinar – How to save time and money with a literature review of clinical data

Free Webinar on September 1st! Content In the 20 minute top-level webinar we will include: Definition of clinical data according to MDR Description of what a literature review is and when applicable Description of state-of-the-art / best practice And how this is linked to potential savings in clinical development timeline and costs Who should attend […]

FREE Webinar – The role of GLP in medical device biocompatibility testing

Toxicology, biological assessments

Free Webinar on August 25th! The webinar aims to highlight: What are my responsibilities as sponsor of a GLP study? What information is required to properly characterize a medical device to fulfil GLP How can I (or an authority/notified body) verify the GLP status of a test report Who should attend Anyone who orders biocompatibility […]