With the European Medical Device Regulation (MDR) looming, medical device companies are focusing on ensuring compliance with the new regulations. One of those key aspects of compliance is to ensure your devices conform to the General Safety and Performance Requirements (GSPR). This guide provides you with some practical guidance on how to meet those requirements.
RIMSYS Regulatory Management Software, the leading Regulatory Information Management (RIM) platform designed specifically for the medical device industry, is proud to announce the creation of its prestigious advisory board.
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:
- 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:
- Multi-product registrations – You can choose 1 or 1000 products (at the part number level) to register simultaneously into one market.
- 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!
- 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!
- Dashboard updates – Added key metrics so your team can all be on the same page
- 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.
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.
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.
(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.
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.
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…
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!