>

Blog

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
FDA’s Final Rule on LDTs: What manufacturers need to know
FDA’s Final Rule on LDTs: What manufacturers need to know
Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams
Evolving global cybersecurity regulations: Challenges and opportunities for medtech teams
FDA listed, cleared, approved, granted - what IS the difference?
FDA listed, cleared, approved, granted - what IS the difference?
Quick reference guide - global medical device UDI requirements and timelines
Quick reference guide - global medical device UDI requirements and timelines
Key steps to help you streamline regulatory process management
Key steps to help you streamline regulatory process management
A look at the FDA Total Product Life Cycle Advisory Program (TAP)
A look at the FDA Total Product Life Cycle Advisory Program (TAP)
Are FDA risk classifications and submissions any different for SaMDs? [VIDEO]
Are FDA risk classifications and submissions any different for SaMDs? [VIDEO]
An introduction to standards for medtech companies
An introduction to standards for medtech companies
Why should you invest in your regulatory team?  Easy Medical Device podcast interview
Why should you invest in your regulatory team? Easy Medical Device podcast interview
Taking SaMDs to market in the US: How is the FDA regulating adaptive machine learning algorithms?
Taking SaMDs to market in the US: How is the FDA regulating adaptive machine learning algorithms?
The five guiding principles for machine learning-enabled medical devices using PCCPs
The five guiding principles for machine learning-enabled medical devices using PCCPs
Rimsys POV: new EUDAMED timeline
Rimsys POV: new EUDAMED timeline
An overview of the Accreditation Scheme for Conformity Assessment (ASCA) Program
An overview of the Accreditation Scheme for Conformity Assessment (ASCA) Program
Your eSTAR submission questions answered by FDA experts
Your eSTAR submission questions answered by FDA experts
Rimsys ranks number 156 on the 2023 Inc. 5000
Rimsys ranks number 156 on the 2023 Inc. 5000
An overview of the Medical Device Discovery Appraisal Program (MDDAP)
An overview of the Medical Device Discovery Appraisal Program (MDDAP)
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?
Selecting and working with medtech regulatory approval consultants
Selecting and working with medtech regulatory approval consultants
Canada medical device regulations
Canada medical device regulations
MDR transition example under the extension
MDR transition example under the extension
Declarations of Conformity
Declarations of Conformity
An overview of 21 CFR Part 812
An overview of 21 CFR Part 812
Content of FDA premarket submissions for device software functions
Content of FDA premarket submissions for device software functions
Selecting a RIM system for your medical device company
Selecting a RIM system for your medical device company
SaaS 101 for medtech regulatory professionals
SaaS 101 for medtech regulatory professionals
Global strategy for Unique Device Identifier (UDI) data
Global strategy for Unique Device Identifier (UDI) data
Educational resources for medtech regulatory affairs professionals
Educational resources for medtech regulatory affairs professionals
FDA predicate devices
FDA predicate devices
Medical device audits - preparation and responses
Medical device audits - preparation and responses
Australian Essential Principles
Australian Essential Principles
RIM - Master data management for RA teams
RIM - Master data management for RA teams
EU country-specific medical device registration requirements
EU country-specific medical device registration requirements
FDA transition plans for Covid-19-related medical devices
FDA transition plans for Covid-19-related medical devices
Nonconformance reporting for medical device manufacturers
Nonconformance reporting for medical device manufacturers
Regulatory strategy as a competitive advantage
Regulatory strategy as a competitive advantage
Essential principles
Essential principles
FDA consensus standards
FDA consensus standards
RIM for medtech vs. RIM for pharma
RIM for medtech vs. RIM for pharma
The role of regulatory affairs teams throughout the product lifecycle
The role of regulatory affairs teams throughout the product lifecycle
RIM vs ERP software for medical device companies
RIM vs ERP software for medical device companies
IEC 62304: Standard for medical device software
IEC 62304: Standard for medical device software
RIM vs PLM software for medical device manufacturers
RIM vs PLM software for medical device manufacturers
The state of regulatory performance in 2023
The state of regulatory performance in 2023
RIM vs eQMS software for medical device manufacturers
RIM vs eQMS software for medical device manufacturers
6 reasons medtech companies shouldn't delay MDR certification
6 reasons medtech companies shouldn't delay MDR certification
ISO 10993: Standards for the biologic evaluation of medical devices
ISO 10993: Standards for the biologic evaluation of medical devices
An overview of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
An overview of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Introducing impact surveys
Introducing impact surveys
Medical Devices: Comparing standards, regulations, directives, guidance, and laws
Medical Devices: Comparing standards, regulations, directives, guidance, and laws
EU MDR transitional period to be extended
EU MDR transitional period to be extended
Making the case for a RIM system
Making the case for a RIM system
To build or to buy: evaluating options for Regulatory Information Management
To build or to buy: evaluating options for Regulatory Information Management
Post-market surveillance for medical devices in the European Union
Post-market surveillance for medical devices in the European Union
Regulatory should be a revenue function
Regulatory should be a revenue function
Ask us Anything ... about China submissions!
Ask us Anything ... about China submissions!
IMDRF: International Medical Device Regulatory Forum
IMDRF: International Medical Device Regulatory Forum
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
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!
Oh No! How to recover lost medical device certificates
Oh No! How to recover lost medical device certificates
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
Announcing Rimsys 5: comprehensive submission management and regulatory intelligence
Announcing Rimsys 5: comprehensive submission management and regulatory intelligence
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
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
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