Blog Archive: RIM Benefits
Quick Reference Guide: Global Medical Device UDI Requirements and Timelines
Keeping track of country-specific UDI requirements, implementation timelines, and affected devices can be a big challenge to RA teams—especially because information is scattered across many sources. This guide consolidates timeline information and device class requirements across multiple regions.
The Ultimate Guide to the China NMPA UDI System and Database
eBook excerpt - In 2019, Chinese medical device regulations added a provision that devices carry a unique device identification (UDI). China's UDI requirements are similar to those in the US and EU. They establish specific device ID and labeling requirements, as well as a central, state-administered device database.
The Ultimate Guide to the EU MDR/IVDR UDI
eBook excerpt - The EU Medical Device Regulation (2017/745) (“MDR”) and EU In Vitro Diagnosis Regulation (2017/746) (“IVDR”) introduce two new systems for information exchange: (1) UDI (Unique Device Identifier) for device identification and (2) EUDAMED (European Databank on Medical Devices) to centralize and disseminate information.
Building a business case for a RIM system
Regulatory information management (RIM) systems are still relatively new to a lot of MedTech companies. RIM systems help companies digitize and automate regulatory activities associated with their products. The value of an automated solution is pretty obvious, but quantifying that value can be harder.
5 ways a RIM system can accelerate time-to-market for MedTech companies
Like all products, time-to-market is a critical success factor for medical technology (MedTech). Unlike other products, however, medical devices have an added hurdle of regulatory clearance that must be obtained before products can be marketed and sold.
Rimsys Releases New Automated Unique Device Identification (UDI) Module for Its Holistic MedTech RIM Platform
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced a new brand identity and tagline. Rimsys, the only holistic RIM software on the market designed specifically for medical technology companies, with functionality for the pillars of regulatory affairs, rebranded to accurately