With the implementation of the new EU Medical Device Regulation (MDR), the compliance requirements of the medical device industry are undergoing a major change. This has resulted in more challenges for the Chinese medical device companies entering the EU market.
In response to this changing market, Altride Healthcare, a wholly owned medical subsidiary of Melchers, LS medcap GmbH and Zeric, Beijing’s first medical device CDMO platform, will co-host a webinar titled “Navigating Chinese Medical Device Companies to the EU Market” at the end of this month:
Date: October 29, 2024
Time: 5pm-6pm (CST) / 10am-11am (CET)
Language: English
Registration link: https://melchers.webinargeek.com/navigating-chinese-medical-device-companies-to-the-eu-market
The webinar will address the following topics:
Session 1: Introduction to CE marking and the EU regulatory framework (MDR)
Session II: Roadmap for MDR implementation
Agenda (Beijing Time):
5:00pm Registration opens
5:00pm – 5:10pm Opening Remarks and Speaker Introductions
5:10pm – 5:50pm Keynote Speeches covering key issues in MDR implementation
5:50pm – 5:55pm Q&A Session, Dialogue with Experts
5:55 PM – 6:00 PM Closing Remarks and End of Workshop
Speakers:
- Dr. med. Tobias Walker, Chief Medical Officer, LS medcap GmbH
- Biol. Frank-Schulte-Hunsbeck, Director Quality Management / Regulatory Affairs, LS medcap GmbH
- Dr. rer. nat. Klaus Graef, Scientific Affairs Manager (Deputy Scientific Affairs), LS medcap GmbH
- Sc. Laura Klink, Junior Clinical Trial Manager (Deputy Clinical Affairs), LS medcap GmbH
- Levin von Gehren, Managing Director, Altride Healthcare Ltd.
- Sylvia Zhang Yinan, General Manager, Zeric Medical Technology (Beijing) Co. Ltd.
You are welcome to register for this free webinar and learn from the experts how to deal with the complexities of entering the EU medical device market.
About the Co-Organizers:
About Altride
Altride is a Hong Kong-based company specializing in the healthcare business and is part of the Melchers Group. Founded in 1806 in Bremen, Germany, Maxima has 25 offices and more than 1,200 employees in Asia.
With over 155 years of experience in doing business in China and the synergies within the Melchers Group, we are committed to being your partner in China to help you take your business to the next level.
Altride provides comprehensive and specialized services to customers in the medical technology, medical consumables, pharmaceutical packaging, pharmaceutical machinery and life sciences sectors.
About LS medcap
LS medcap is your strategic partner for the entire lifecycle of your medical device products. We combine deep scientific and clinical expertise to provide customized solutions that help medical device manufacturers successfully enter the European market.
As an entrepreneurial family-owned company with deep roots in the life sciences, LS Healthcare has established and invested in innovative start-ups and small and medium-sized medical device companies in various European countries since its founding in Germany in 1999.
Our Medical Device Services business unit provides comprehensive and in-depth scientific and clinical services to European and international medical device companies, helping them to develop and grow in the European market and to successfully address regulatory challenges. Our clients are medical device companies with a global outlook, seeking to grow internationally.
With years of industry experience and clinical practice, LS Healthcare’s team of professionals, through the collaboration of our interdisciplinary departments, provides you with comprehensive support throughout the lifecycle and at every stage of a medical device product’s life cycle, from pre-market to post-market, including but not limited to:
- Scientific Affairs
- Clinical Affairs
- Quality Management/Regulatory Affairs
About Zeric Medical Technology
Zeric Medical Technology (Beijing) Co., Ltd. is a comprehensive service provider specializing in R&D and contract manufacturing (CDMO), registration, quality system construction and clinical trials (RO) for medical devices, pharmaceuticals, cosmetics and sterilization products. We can provide one-stop service for global customers to enter China.
Now we have four professional teams in R&D, GMP construction and production, CRO clinical trial and registration declaration, whose main members are senior experts from multinational enterprises and domestic manufacturers. In addition to domestic pharmaceutical companies, our clients come from more than 30 countries and regions, including the United States, Switzerland, Germany, Israel, Japan, South Korea and Taiwan.
Relying on the State Drug Administration and the Beijing Municipal Drug Administration to give the first pilot and vertical communication mechanism, with experienced technical service team, for biopharmaceutical enterprises product development and production, clinical trials and registration declaration of each link to provide the most reliable and fastest service.
If you have any questions about this webinar, please feel free to contact:
Serina Yue
Account Manager
serina.yue@altridehc.com
+86-158 1114 8019