First and foremost, we hope everyone has a safe and healthy New Year!

2018 was a great year at RIMSYS and 2019 is starting off just as strong.

We are excited to announce that we have teamed up with Right Submission, LLC to release a regulatory insight content series catered specifically to the medical device industry.  Combining decades of regulatory expertise and behind-the-scenes knowledge, this new partnership will provide unparalleled value to its current and future customer base which includes thousands of regulatory affairs professionals.  You can check out our full press release here and our first content piece here: 2018: A Year of FDA Regulatory Changes to the 510(k) Process and Why it Matters to You.

If you haven’t heard of Right Submission, you are in for a treat.  Right Submission is a software solution provider specifically catered to the medical device industry (just like RIMSYS) and has developed a SaaS-based tool that creates high quality 510(k) applications ready for submission while meeting FDA’s technical and style requirements.  It utilizes a guided process reducing resource requirements, cost, and time, strengthening the content of your submission and streamlining workflows.  They also have other tools to help with your Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and researching the correct regulatory pathway.  You can check out all of their products here.

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!