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.
https://www.rimsys.io/wp-content/uploads/2019/06/EBOOK-Ultimate-Guide-EU-MDR-GSPR-Cover-Page.png33002550RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-06-26 13:47:032019-07-16 10:15:05The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)
The medical device industry is in dire need of robust, practical and easy-to-use software to make regulatory professionals’ lives easier. Without a unified, collaborative, and regulatory digital system, serious consequences to a business…
https://www.rimsys.io/wp-content/uploads/2019/04/5-signs-you-are-ready-to-take-your-medical-device-regulatory-team-digital.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-04-25 11:45:312019-04-25 11:49:065 signs you are ready to take your medical device regulatory team digital
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.
https://www.rimsys.io/wp-content/uploads/2019/04/RIMSYS-Advisory-Board.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-04-05 08:51:222019-04-05 14:26:14Announcing the RIMSYS Advisory Board
Often, the first thing we hear from a consultant or a medical device company regarding an FDA 510(k) premarket notification is that it was delayed because the FDA reviewer did not understand something simple within the application, or completely…
https://www.rimsys.io/wp-content/uploads/2019/02/The-510k-Application-–-If-Content-is-King-then-Communication-is-Queen.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-02-07 12:54:312019-02-07 14:32:02The 510(k) Application: If Content is King, then Communication is Queen
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…
https://www.rimsys.io/wp-content/uploads/2019/02/Government-Submission-Templates-Medical-Devices.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-02-06 13:50:092019-02-06 14:01:11Introducing Government Submission Templates (i.e. 510k, STED, CSDT) and more!
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…
https://www.rimsys.io/wp-content/uploads/2019/01/RIMSYS-Right-Submission.png10601552RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2019-01-03 10:17:092019-01-03 10:17:11RIMSYS and Right Submission Team Up!
What is the Medical Device Single Audit Program (MDSAP)?
The International Medical Device Regulators Forum (IMDRF) recognized that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety…
https://www.rimsys.io/wp-content/uploads/2018/11/MDSAP-Device-Registration-Facility-Registration.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2018-12-02 20:30:522018-12-10 19:44:16MDSAP Device Marketing Authorization and Facility Registration
I had the opportunity to sit down with Jon Speer, Founder & VP of QA/RA at Greenlight Guru to record a podcast to discuss streamlining the MDSAP Marketing Authorization & Facility Registration Process.
If you are not familiar…
https://www.rimsys.io/wp-content/uploads/2018/11/podcast_james-1.png24002392RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2018-11-25 18:57:112018-11-25 20:52:52Podcast - Streamlining the MDSAP Device Marketing Authorization and Facility Registration Process
The medical device and in-vitro diagnostic medical device industry are in dire need of a robust, practical and easy to use regulatory information management (RIM) system. Without a unified and collaborative system, serious consequences…
https://www.rimsys.io/wp-content/uploads/2018/11/Top-6-Benefits-of-a-Regulatory-Information-Management-RIM-System-Medical-Devices.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2018-11-04 22:50:352018-11-25 19:10:17Top 6 Benefits of a Regulatory Information Management (RIM) System for Medical Devices
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)
RIMSYS' own James Gianoutsos recently contributed an article on www.meddeviceonline.com discussing FDA's guidance document describing accessories and classification pathways.
The guidance explains which devices FDA generally considers…
https://www.rimsys.io/wp-content/uploads/2018/06/IS-A-MEDICAL-DEVICE-ACCESSORY-A-MEDICAL-DEVICE_.png300300RIMSYShttps://www.rimsys.io/wp-content/uploads/2018/09/RIMSYS-Logo.pngRIMSYS2018-06-15 19:28:092018-11-07 14:58:21Is a medical device accessory a medical device?
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