Managing device registrations and certificates typically involves labor intensive, highly manual efforts from medical device manufacturers’ Regulatory Affairs (RA) departments. Registration management entails four mission critical elements:
- Tracking the regulatory status of a manufacturer’s entire product line,
- Becoming aware of the latest global medical device regulations,
- Communicating crucial registration status notifications to key stakeholders and taking necessary action, and
- Determining when changes to a device require amendments to a registration, or applying for a new registration.
RAMS-TRACK is a new web-based application designed to help manufacturers manage and track their product registrations with ease. In this case study, we examine how three manufacturers’ RA teams are using RAMS-TRACK to stay on top of global regulatory trends, as well as actively track registrations and certificates for their entire product lines.