10 months ago
70 1MED, a specialist Contract Research Organisation (CRO) providing clinical and regulatory support to medical devices companies, is participating as a sponsor and exhibitor at the 12th Annual Outsourcing in Clinical Trials: Medical Devices Europe Conference in Munich.
As the Medical Device Regulation (MDR) becomes fully applicable to all medical devices from 27 May 2024, 1MED is set to showcase solutions to support medtech companies in meeting crucial 2024 MDR deadlines.
At the heart of 1MED ‘s offerings is the 1MED Compliance Pack, a tool designed to facilitate the recertification process for medical device companies. This tool identifies documentation gaps, streamlining the submission process to Notified Bodies and simplifying compliance with the MDR’s standards.
Additionally, 1MED introduces 1SURVEY, a Real-World Data collection tool. The digital platform allows medical device manufacturers to make informed, data-driven decisions and improve patient care through proactive measures. From generating questionnaires to digital implementation, 1SURVEY provides a solution for gathering clinically relevant information on medical devices.
1MED founder Enrico Perfler said: “This two-day event is a golden opportunity for the European medtech and diagnostics community to gain fresh insights into regulatory changes and strategies to tackle them. At 1MED, our journey in medtech is marked by deep expertise and a commitment to innovation. We look forward to showcasing the valuable assistance we can offer to help companies navigate and overcome the complexities of the new regulatory framework.”
The year 2024 is pivotal for the medtech sector, with critical deadlines for the recertification of legacy devices under the new MDR. By 26 May 2024, companies must have submitted their legacy devices for recertification, and by 26 September 2024, they must sign an agreement with a Notified Body.
