1med
Combining Customized Regulatory Strategy with Digital Capability

Europe’s medical devices sector is waking up to the compliance challenges of Medical Device Regulation (MDR) that raise the risk of penalties, remediation costs, and reputational damage. From the unstandardized application of MDR rules across the European Union to the inadequate capacity of notified bodies for certification and recertification, there are multiple headwinds for the innovative endeavors of medical device manufacturers. They need a customized regulatory strategy and digital capability to battle these headwinds.

This is precisely what 1MED offers. A full-service CRO, it combines its expertise in regulatory strategy, clinical trial management, and quality assurance with digital capabilities to streamline the complete lifecycle of medical device development.

“We create digital tools that put manufacturers at the center so they can reduce the costs and timelines for developing their products. Our solutions reduce the contribution of external consultants in performing the activities needed for compliance with MDR,” says Enrico Perfler, CEO of 1MED.

Devoid of any grandfathering provision, the new regulations make it cumbersome for existing medical devices to be recertified. Aware of this need for better clarity about the pathway, 1MED has positioned itself as a CRO and regulatory expert. It supports clients in their medical investment to help them find a solution for meeting the tight deadlines of regulatory compliance.

Innovation gets impeded when it comes to new product development as the system fulfills the recertification commitments for existing products. Reinventing a CRO’s role, it minimizes external consultants’ contribution to performing MDR compliance activities.

Undergoing a metamorphosis from a boutique traditional CRO to a digital CRO, 1MED has introduced a new product suite with AI and ML capabilities to automate processes like clinical data collection and analysis. The first product itreleased is 1SURVEY, a real-world data collection solution. It can be used to collect information from patients or end users and from a physician, a distributor of medical devices, or other stakeholders that one wants to engage. It supports manufacturers with the survey’s design, implementation, distribution, data management, and reporting phase. Easy to use, cost-effective, and GDPR compliant, it collects valuable information from the market and monitors the product’s usability, safety, and performance once it is marketed.
The second product offered by 1MED is 1FILE, a digital tool for managing technical documentation. Manufacturers can create the necessary structure for their technical files through the solution. Each section of the technical file can be designed per regulatory models, constantly updated with changing compliance requirements.

1MED has been working with over 15 notified bodies in Europe and has certified more than 500 medical devices with 100 percent success, proving its reliability. It ensures the manufacturer complies with the expectations of the notified body, reducing the risk of rejection and bringing down the time and cost for regulatory compliance of the products. In contrast to the usually restrained approach of CROs, 1MED raises the client’s awareness, making it capable of managing compliance with the digital tools at its disposal.