Live Webinar: Chemical Testing - Managing the EU MDR Impact of Hazardous Substances in Medical Products
MDR and the impact on chemical substances in Medical Products
Since 26th May 2021, the new Medical Device Regulation 2017/745 (MDR) has been fully implemented. Aside from documentation and certification procedure requirements, there are also new hazardous substance control requirements. TÜV Rheinland, as a Notified Body, is authorized to conduct testing for medical devices covered by both MDR and IVDR regulations.
In this upcoming webinar, our experts will discuss how Chemical Testing is critical to managing the EU MDR Impact of Hazardous Substances in Medical Products. Furthermore, our experts will also provide an overview of the changes for hazardous substances, challenges for risk assessment, and examples of actual tests with their associated results.
Agenda:
- Introduction to Timeline
- MDR Annex I (GSPR)
- Overview of the changes about hazardous substances
- Impact on the risk assessment
- Examples of substances discovered in Medical Devices
- Q&A
Webinar Details:
Date: 21 April 2022
Time: 1.00 - 2.00 PM (Indonesia, Thailand, Vietnam - GMT +7)
2.00 - 3.00 PM (Singapore, Malaysia, Philippines - GMT +8)
Duration: 1 Hour
Language: English
Fee: Complimentary
Featured Speakers:
1. Dr. Morwan Choli - Vice President (Medical Devices), APAC
Dr. Choli started his career after obtaining a PhD on “Novel MRI imaging techniques for ultra-high magnetic field systems” in the area of brain imaging of MS patients. As a consultant and as part of several standardization committees, Dr. Choli influenced the landscape of MRI safety and compatibility for medical devices.
In 2013, he started working for notified bodies, managing various teams in Germany before moving to Japan in 2018.
Today, Dr. Choli leads TÜV Rheinland’s Medical Testing and Certification Team as Regional Manager, responsible for an extended team of experts and managers located in 7 countries across APAC.
2. Mr. Frank Juettner - Managing Director and Regional Manager for Chemical and Mechanical Testing Services in Asia-Pacific (Softlines and Hardlines)
Mr. Juettner is currently the Regional Manager for Chemical and Mechanical Testing Services in Asia-Pacific (Products - Softlines and Hardlines). With over 20 years of global working experience, he is the go-to industry expert for both chemical analysis and product regulations.
During his career, he has led high-value projects and served in various leadership roles within TÜV Rheinland.
Currently, he is also the Representative Director and CEO of TÜV Rheinland Korea. Frank is a Chemical Engineer (Environmental Chemistry) by profession and he also holds an MBA from Solvay Brussels School of Economics and Management.
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