1MED, a Contract Research Organisation known for its expertise in clinical and regulatory support for medical device companies, is making its presence known as a sponsor and exhibitor at the 12th Annual Outsourcing in Clinical Trials: Medical Devices Europe Conference in Munich. With the full application of the Medical Device Regulation (MDR) on the horizon, 1MED is prepared to present its solutions to assist medtech companies in meeting the approaching 2024 MDR deadlines.
Introducing the 1MED Compliance Pack
Central to 1MED’s suite of tools is the 1MED Compliance Pack, which has been crafted to ease the recertification process for medical device manufacturers. This comprehensive tool aids in identifying gaps in documentation and streamlines the process of submission to Notified Bodies, thereby making compliance with MDR standards more manageable.
1SURVEY: A Real-World Data Collection Tool
In addition to the Compliance Pack, 1MED has unveiled 1SURVEY, a platform designed for the collection of Real-World Data. This digital tool empowers manufacturers to base their decisions on solid data, ultimately enhancing patient care by enabling proactive strategies. 1SURVEY simplifies the collection of critical data, from the creation of questionnaires to their digital deployment.
Enrico Perfler, founder of 1MED, emphasized the importance of the conference as an opportunity for the European medtech community to gain insights into regulatory changes and to discover new strategies for addressing them. He highlighted 1MED’s dedication to innovation and expertise within the medtech field, expressing eagerness to demonstrate how the company can assist others in navigating the complex new regulatory environment.
The year 2024 stands as a significant milestone for the medtech industry, with essential deadlines looming for the recertification of existing devices under the new MDR. By May 26, 2024, companies must have their legacy devices submitted for recertification, and by September 26, 2024, they are required to secure an agreement with a Notified Body.
