Amidst a constantly-changing global regulatory landscape, swiftly and successfully adapting to the latest regulatory changes is important to ensure medical device companies’ ability to market their devices compliantly without disrupting market access. In 2017, the European Union adopted a new regulatory framework for medical devices, Medical Device Regulation 2017/745 (EU MDR 2017/745). With the deadline for compliance quickly approaching on May 26, 2021, understanding the EU MDR’s new requirements for medical devices is essential to maintaining market access.
One of the most significant changes to the EU’s new medical device regulatory framework are new standards for medical device labeling, as well as safety, block chain, and other areas. In this webinar, the panelists will succinctly explain changes in the EU MDR’s labeling requirements, common challenges and important considerations for medical device companies when complying with the EU MDR’s new labeling translation regulations, and how language service providers can ensure medical device companies leverage best practices to ensure all labelling, safety data, and other important aspects are compliant with EU MDR 2017/745 guidelines.
Register for this webinar to learn more about the EU MDR’s labelling and other requirements for medical devices.
Mattias Schroeter, Business Development Director, CSOFT Health Sciences
Mattias has pursued his passion in helping Med Device and Pharmaceutical companies globally for 12+ years with a primary focus on: Clinical Trials, Regulatory Compliance, H.E.O.R, Market Access and Pharmacovigilance. He has several degrees in marketing, economics, software engineering and German. As a strong believer in giving back to the community, he served as Vice Chairman and is a current board member for a not-for profit: The Center for Educational Advancement, which helps those with disabilities receive an education and career opportunities. He currently proudly supports and serves his local community as Mayor.Message Presenter
Di Lv, Chief Life Science Practice Lead & Executive Director, CSOFT Health Sciences
Di Lv has worked in the international healthcare market for the past 8years. With a deep understanding of China’s healthcare and regulations, Direceived her first law degree in China and then pursued further studies in the UK, obtaining a second law degree with a focus in human rights. Placing high value on continued educational development, she earned a second M.S. degree in management. Entering the healthcare market in 2010, Di first worked in the drug discovery field. Her work took her to Belgium and Germany as a Business Development Manager, calling on clinical institutions, medical schools and pharmaceutical companies.Message Presenter
Who Should Attend?
Managers and above at medical device and biotech companies with job functions including, but not limited to:
- Product Labelling
- Global Marketing
- Product Safety
- Product/Program Management
- Quality Assurance
- Regulatory Affairs
- Technical Writing
- Localization Management
What You Will Learn
In this webinar, participants will learn:
- What the major labeling changes are within EU MDR
- Important EU MDR labeling questions that manufacturers should consider
- The importance of labeling and safety content translation
- How language service providers (LSPs) ensure translated content is accurate and effective
CSOFT Health Sciences
CSOFT Health Sciences provides end-to-end medical translation services for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.