Regulatory Updates

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octobre 03, 2023

"Toetsingskader Post-Market Surveillance | IGJ | September 2023 | Version 1.7"

septembre 08, 2023

Free Webinar PDF Download | Medical Device Registration in Asia-Pacific Part II

Australia Global Registration Inde Malaisie Réglementations des dispositifs médicaux Nouvelle-Zélande Affaires réglementaires Regulatory strategy Webinaire

juillet 25, 2023

Free Webinar Q&A Document | Medical Device Registration Asia-Pacific part I

Chine Market Access China Réglementations des dispositifs médicaux Affaires réglementaires Singapour Webinaire

juillet 17, 2023

Diane Ward, IVD development expert, contributed to design the studies used in the article of the Journal of Microbiological Methods

Performance evaluation of InfectID-BSI: A rapid quantative PCR assey for detecting sepsis-associated organisms directly from whole blood

Clinical Affairs Clinical Data Clinical Performance Studies CLSI In-Vitro Diagnostics IVDR Affaires réglementaires

juillet 06, 2023

Free Webinar Q&A Document | Recommendations for Clinical Performance Studies under IVDR

Clinical Performance Studies In-Vitro Diagnostics IVDR Clinical Affairs Clinical Data Webinaire

juillet 05, 2023

Free Webinar Q&A Document | Training Methods and Monitoring of Effectiveness for Medical Device Manufacturing Personnel

Dispositifs médicaux On-Demand Webinar Q&A Affaires réglementaires Virtual Training

juillet 04, 2023

Free Webinar Q&A Document part I | How to Minimize the Pain of Getting Your Technical Documentation Through the Notified Body Review

Download part I of the Q&A during the Free Webinar | How to Minimize the Pain of Getting Your Technical Documentation Through the Notified Body Review.

Réglementations des dispositifs médicaux Notified Body-Like-Review Q&A Technical Documentation

Free Webinar PDF Download | Medical Device Registration in Asia-Pacific Part I

Chine China Agent Global Registration Market Access China Réglementations des dispositifs médicaux NMPA Affaires réglementaires Regulatory strategy Singapour Webinaire

Free Webinar PDF Download | Recommendations for Clinical Performance Studies under IVDR

Clinical Affairs Clinical Performance Studies In-Vitro Diagnostics IVDR Webinaire

Free Webinar Q&A Document | EU-IVDR one year on

CE Certification In-Vitro Diagnostics IVDR Notified Body Affaires réglementaires Highlights

Free Webinar PDF Download | EU-IVDR one year on!

In-Vitro Diagnostics IVDR Webinaire

Free Webinar Q&A Document | Biocompatibility: Tips and Tricks for Sample Selection for Your Biological Evaluation

Biocompatibilité Réglementations des dispositifs médicaux Q&A

Free Webinar Q&A Document | Post-Market Surveillance – Expectations of a Maturing System and Preventing Analysis Paralysis

Réglementations des dispositifs médicaux Q&A

Free Webinar Q&A Document | Medical Device Sterilization – Addressing EPA’s Clean Air Act

Dispositifs médicaux Webinaire

Free Webinar Q&A Document | UK Vigilance reporting the new MORE portal

Download the Q&A Document of the Free Webinar | UK Vigilance reporting the new MORE portal

UKCA Webinaire CE Approved CE Certification

décembre 05, 2022

Free Webinar PDF Download | Introduction to the 60601 family of standards

décembre 05, 2022

Free Webinar PDF Download | Tips and Tricks on How to Get Started with a Clinical Study under MDR

Clinical Affairs Contract Research Organization CRO

novembre 17, 2022

Free Webinar Presentation Download | Developments in the world of local representation

Download the PDF of the presentation hosted by Daniëlle Motta, Jennifer Hadfield and Stefan Menzl

China Agent EAR EC REP European European Authorized Representative Global Registration Legal agent Legal representation Swiss rep UK Responsible Person

novembre 15, 2022

Free Webinar PDF Download | The Exciting and Challenging world of Software AI/ML and incorporating risk management principles for designing a safe Medical Device

AI Réglementations des dispositifs médicaux Gestion des Risques

octobre 27, 2022

Free Webinar Q&A Document | A year+ after MDR implementation - All we have learned

Download the Q&A Document of the free webinar Free Webinar: A year+ after MDR implementation - All we have learned hosted by Robert Paassen.

Webinaire Highlights

octobre 26, 2022

News on the UK Regulations for medical devices and IVDs – an extension of the standstill period

The MHRA published an announcement on the future regulation of medical devices. There will be an extension of the standstill period.

MHRA In-Vitro Diagnostics Dispositifs médicaux Highlights

octobre 07, 2022

Free Webinar Q&A Document | The essence of MDSAP++ country-specific QMS demands - What is it all about and lessons learned

Download the Q&A Document of the Free Webinar: The essence of MDSAP++ country-specific QMS demands - What is it all about and lessons learned by Olena Hoi and Henk-Willem Mutsaers.

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