Regulatory Updates

十月 03, 2023

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

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九月 08, 2023

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

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七月 25, 2023

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

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七月 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
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七月 06, 2023

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

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七月 05, 2023

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

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七月 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. 
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六月 29, 2023

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

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六月 27, 2023

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

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六月 26, 2023

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

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五月 25, 2023

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

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四月 13, 2023

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

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四月 12, 2023

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

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三月 08, 2023

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

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三月 02, 2023

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
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十二月 05, 2022

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

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十二月 05, 2022

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

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十一月 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
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十一月 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

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十月 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.
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十月 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.
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十月 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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