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 […]

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 […]