Directly on the heels of our new User Interface (UI) released at the end of September and debuting at the RAPS Regulatory Convergence in October, we are proud to announce another HUGE release.‍

Project management (for large and small teams)

Properly managing registrations across the world with dozens of stakeholders trying to collaborate on critical information is challenging enough, so we just made it easier for enterprise and large teams to manage everything.

The project management features were frequently requested and will set Rimsys up for further development of Key Performance Indicators (KPIs) to monitor the efficiency of your team and the registration process.

It will also allow Rimsys to further expand reporting capabilities and dashboard metrics so you can easily track and analyze data specific to your team, registrations, products, and countries.

• Registration owner - Assign an owner so you know who is responsible for each registration
• Anticipated approval date - Identify an anticipated approval so you can forecast product releases with other departments
• Registration start date - Automatically creates the registration start date so you can monitor exactly how long a registration takes from start to finish.
• Registration lifecycle stages - Whether you are in the discovery, planning, execution or submission stage of the registration process, you can now keep track with your own configurable buckets.
• Kanban boards - Visually see your registrations in each lifecycle stage and transition them into new stages by a simple drag n’ drop interface.

Essential principles (expansion of templates)

We always had a grander plan in mind. Rimsys was originally set up to include the new EU Medical Device Regulation (MDR) 2017/745 Annex I General Safety and Performance Requirements (GSPR) but now supports Essential Principles Templates that include:

• IVDR 2017/746EU IVDR GSPR
• Australian (TGA) Essential Principles
• Japan (PMDA) Essential Principles
• GHTF/SG1/N68:2012 IMDRF Essential Principles
• Directive 2006/42/EC – Machinery Directive
• and more to come!

The essential principles expansion complies with country entrance requirements and will set Rimsys up for further development of correlation tables. What are correlation tables you ask? Think of this….you create the general safety and performance requirements table for the EU MDR, then with a click of a button, you create the essential principle tables that meet the requirements for all other countries. More to come…

What’s next?

Next month, we will be making a few more major announcements that will bring you new and even better features that will drastically create more value to your company and team. We can’t wait to share the news with you…stay tuned!