Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Executives we’ve talked to have stated:
- “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
- “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”
Are you lost? Access our Infographic for a road map to sustainable, positive disruption and see for yourself why Digital Transformation is a journey to EU MDR and beyond. We’ve identified some road hazards and areas of interest along the way.
With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.
Register to receive the Infographic today and keep an eye out for additional information.