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Introduction to Notified Bodies
Introduction to Notified Bodies
MedWatch: The FDA safety information and adverse event reporting program
MedWatch: The FDA safety information and adverse event reporting program
An overview of 21 CFR Part 820
An overview of 21 CFR Part 820
What is the FDA eSTAR program?
What is the FDA eSTAR program?
FDA Class II medical devices
FDA Class II medical devices
What's up with the duck?
What's up with the duck?
Brexit overview for medical device manufacturers
Brexit overview for medical device manufacturers
The RegUP rundown
The RegUP rundown
Team member spotlight: Denise Moon
Team member spotlight: Denise Moon
IVDR: In Vitro Diagnostic Regulation within the European Union
IVDR: In Vitro Diagnostic Regulation within the European Union
CE marking guide for medical devices in the European Union
CE marking guide for medical devices in the European Union
Ask us Anything ... about UDI!
Ask us Anything ... about UDI!
Quick reference guide - global medical device UDI requirements and timelines
Quick reference guide - global medical device UDI requirements and timelines
Oh No! How to recover lost medical device certificates
Oh No! How to recover lost medical device certificates
Rimsys POV: new EUDAMED timeline
Rimsys POV: new EUDAMED timeline
Class III medical devices in the United States
Class III medical devices in the United States
BUDI-DI - Basic UDI explained
BUDI-DI - Basic UDI explained
RIM Readiness: What your medtech company needs before implementing a regulatory information management system
RIM Readiness: What your medtech company needs before implementing a regulatory information management system
ISO 14971: risk management for medical device manufacturers
ISO 14971: risk management for medical device manufacturers
Why we developed Rimsys from the ground up
Why we developed Rimsys from the ground up
The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)
The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)
On a mission to improve global health
On a mission to improve global health
FDA PMA submission process: a beginner's guide
FDA PMA submission process: a beginner's guide
FDA medical device registration process - getting new products to market in the U.S.
FDA medical device registration process - getting new products to market in the U.S.
EU MDR overview - a major update to European medical device regulations
EU MDR overview - a major update to European medical device regulations
ISO 13485 overview - quality management requirements for medical device companies
ISO 13485 overview - quality management requirements for medical device companies
Your regulatory team needs dedicated regulatory software
Your regulatory team needs dedicated regulatory software
FDA listed, cleared, approved, granted - what do these mean, and what’s the difference?
FDA listed, cleared, approved, granted - what do these mean, and what’s the difference?
21 CFR Part 11 for regulatory affairs teams
21 CFR Part 11 for regulatory affairs teams
The importance of PLM, eQMS, and RIM systems for medical device manufacturers
The importance of PLM, eQMS, and RIM systems for medical device manufacturers
Software as a medical device (SAMD) - classification overview
Software as a medical device (SAMD) - classification overview
PSUR: Periodic safety update reports for medical device and in vitro diagnostic products
PSUR: Periodic safety update reports for medical device and in vitro diagnostic products
De Novo classification process: a beginner's guide
De Novo classification process: a beginner's guide
GUDID: An overview of the FDA's Global Unique Device Identification Database
GUDID: An overview of the FDA's Global Unique Device Identification Database
Rimsys raises $16M Series A to bring regulatory order to the medtech industry
Rimsys raises $16M Series A to bring regulatory order to the medtech industry
RIM 101: what is regulatory information management?
RIM 101: what is regulatory information management?
Regulatory information management (RIM) systems and organizational change management
Regulatory information management (RIM) systems and organizational change management
A primer on medical device classification
A primer on medical device classification
MDSAP - the ultimate guide to the medical device single audit program
MDSAP - the ultimate guide to the medical device single audit program
Rimsys joins MedTech Europe
Rimsys joins MedTech Europe
Better together: regulatory intelligence and regulatory information management
Better together: regulatory intelligence and regulatory information management
FDA 510(k) - a beginner's guide
FDA 510(k) - a beginner's guide
EUDAMED and UDI in Europe: an overview
EUDAMED and UDI in Europe: an overview
Tackling regulatory continuity: How regulatory affairs teams can use technology to reduce the impact of employee turnover
Tackling regulatory continuity: How regulatory affairs teams can use technology to reduce the impact of employee turnover
Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?
Competent Authority, Notified Body, Authorized Representative – who’s who and what do they do?
The ultimate guide to the China NMPA UDI system and database
The ultimate guide to the China NMPA UDI system and database
The ultimate guide to the EU MDR/IVDR UDI
The ultimate guide to the EU MDR/IVDR UDI
Dispatches from RAPS Convergence: The state of regulatory tools
Dispatches from RAPS Convergence: The state of regulatory tools
Building a business case for a RIM system
Building a business case for a RIM system
5 ways a RIM system can accelerate time-to-market for MedTech companies
5 ways a RIM system can accelerate time-to-market for MedTech companies
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys secures $1.5 million to accelerate growth of its leading medtech regulatory information management platform
Rimsys secures $1.5 million to accelerate growth of its leading medtech regulatory information management platform
Rimsys announces new brand identity for world-leading regulatory information management (RIM) software
Rimsys announces new brand identity for world-leading regulatory information management (RIM) software
Announcing the release of Rimsys 3.0: Rimsys Insight
Announcing the release of Rimsys 3.0: Rimsys Insight
5 signs you are ready to take your medical device regulatory team digital
5 signs you are ready to take your medical device regulatory team digital
Announcing the Rimsys advisory board
Announcing the Rimsys advisory board
The 510(k) application: if content is king, then communication is queen
The 510(k) application: if content is king, then communication is queen
Introducing government submission templates (i.e. 510k, STED, CSDT) and more!
Introducing government submission templates (i.e. 510k, STED, CSDT) and more!
MDSAP device marketing authorization and facility registration
MDSAP device marketing authorization and facility registration
Top 6 benefits of a regulatory information management (RIM) system for medical devices
Top 6 benefits of a regulatory information management (RIM) system for medical devices
Introducing project management and essential principle templates
Introducing project management and essential principle templates
Is a medical device accessory a medical device?
Is a medical device accessory a medical device?
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process
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