CSOFT Health Sciences Releases MDR White Paper to Support EU Medical Device Compliance

BOSTON, Feb. 8, 2024 /PRNewswire/ — CSOFT Health Sciences, leaders in clinical trial translation, are pleased to announce the launch of their co-authored white paper for medical device manufacturers seeking re-certification under the updated EU Medical Device Regulation (EU MDR), in collaboration with partner organizations Gouya Insights and GCP-Service International Ltd. & Co.KG to jointly offer manufacturers an end-to-end platform for establishing conformity with policies set to take effect by January 2028.

By the last day of 2027, over half of a million medical devices currently approved for sale in the European Union will need to have achieved recertification of compliance with the MDR. As part of the re-certification process and depending on their risk class the device manufacturers will need to either demonstrate safety and performance of their products using real world data collected as part of their routine medical use and/or demonstrate safety and performance using data generated in clinical investigations.

This white paper was a joint effort led by Dr. Vladimir Misik, VP Global Clinical Trials Strategy, CSOFT Health Sciences, and was co-authored with industry experts: Dr Ghazaleh Gouya-Lechner, CEO of Gouya Insights, as well Dr Andreas Beust, CEO of GCP Services International. Dr. Misik brings more than 30 years of biomedical R&D experience. On the occasion of the launch of the authoritative paper prepared on this topic Dr Misik said:

“The challenge of re-certification of med-tech devices in the EU to comply with EU Medical Device Regulation (EU MDR) looms large for med-tech manufacturers as we outlined in our recent white paper on the topic, this white paper not only outlines the challenge but also offers actionable process guidance.”

CSOFT along with our partners are here to support your needs. To access our latest white paper, please visit: https://lifesciences.csoftintl.com/whitepapers/ensuring-mdr-compliance-looming-challenges-in-the-eu-for-medical-device-manufacturers/ or to learn more about CSOFT Health Sciences and our Medtech partners, contact us at [email protected]

About CSOFT Health Sciences

CSOFT Health Sciences, leaders in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in eCOA documentation including linguistic validation and are capable of supporting CTD/eCTD submissions with the FDA, EMA, and NMPA. Our language and technology supported solutions help to improve patient diversity in clinical trials. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions.