Introducing Government Submission Templates (i.e. 510k, STED, CSDT) and more!

Introducing Gov't Templates



Rimsys released a major revision on Dec. 3, 2018 that included adding registration workflows, registration owners, Kanban boards, new registration dates (e.g. anticipated approvals dates) and registration lifecycle stages.


Rimsys has been working aggressively over the last month to finish up the final touches on our next release, and we are excited to tell you that it has been officially released!  These new features will benefit any size of an organization and continues our pathway to better serving the regulatory affairs professionals in the medical device industry.


Here are a few of our features released:

  1. Document templates – Depending on where you are registering your product, you can now choose or create your own document template that your team can follow to keep you compliant, better organized, and standardize your regulatory process.  A few of our templates include:
  2. Multi-product registrations – You can choose 1 or 1000 products (at the part number level) to register simultaneously into one market.
  3. Bulk search & replace for essential principles – We have been working with a few of our customers to get this functionality rolled out by the beginning of January.  You now have the ability to search / replace / or remove a standard or a document throughout multiple essential principle tables simultaneously.  Let’s say you are managing 10 (or even 500) essential requirements checklists…with a few clicks of a button, you can search, find and replace 1 (or all) standards or documents in EVERY table!  If you have ever managed an essential requirements checklist before, we can’t stress enough of how HUGE of a time saver this is for you and your team!
  4. Embedded documents in essential principles – We now automatically embed your objective evidence directly into the Essential Principles PDF record.  This means that when you export your essential principles as a PDF, every single document that is linked to it will be embedded directly into the searchable PDF.  You never have to go looking for documents again!
  5. Dashboard updates – Added key metrics so your team can all be on the same page
  6. Expanded reporting capabilities – Added the ability to drill-down into key metrics


With this release, Rimsys will be better positioned to cater to organizations of all sizes.  We have even more features and modules coming out in the coming months that will further enhance the benefit you receive from using Rimsys.

What’s Next?


Rimsys has been working hard to be the single source of truth of all things regulatory related for medical devices.  One of the most frequently requested features from our customers is the ability to bring regulatory updates on regulations, laws and guidance documents directly into Rimsys.  We are happy to report that this feature has been in development for quite some time and we will be releasing in the next couple of months.

Rimsys is a world-leading provider of Regulatory Information Management (RIM) software designed specifically for the medical device industry. Rimsys offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, UDI requirements, regulatory documents, changing regulations and more.