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The state of regulatory performance in 2023

Introducing the 2023 Regulatory performance report, a new set of insights into the state of medtech regulatory affairs. Based on a survey of 200 regulatory professionals, the report explores regulatory staffing, workload, compliance issues, and the role of technology in the function.

The state of regulatory performance in 2023

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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

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

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

STED is dead

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

Product Updates

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!

FDA databases

IMDRF: International Medical Device Regulatory Forum

IMDRF: International Medical Device Regulatory Forum

Ask Rimsys!

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?

RAPS wrap-up

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!

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

Announcing Rimsys 5: comprehensive submission management and regulatory intelligence

Product Updates

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

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

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

Product Updates

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