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FEATURED

Introducing Rimsys Intel: A Free, Centralized Global Regulatory Intelligence Hub for Medtech

Rimsys is thrilled to announce the beta launch of its free, community-driven global regulatory intelligence database, Rimsys Intel. Rimsys Intel marks the next step forward in Rimsys’ mission to improve the availability of life-saving medical technologies. Join the beta waitlist here!

Introducing Rimsys Intel: A Free, Centralized Global Regulatory Intelligence Hub for Medtech

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Rimsys POV: Updated EUDAMED timeline

Rimsys POV: Updated EUDAMED timeline

Rimsys secures $5 million in growth financing round

Rimsys secures $5 million in growth financing round

Insights from the Gens and Associates Executive Podcast with James Gianoutsos

Insights from the Gens and Associates Executive Podcast with James Gianoutsos

Rimsys NPI is here: Streamlined new product introduction for faster market entry

Product Updates

Rimsys NPI is here: Streamlined new product introduction for faster market entry

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

Rimsys UDI Overview

Product Updates

Rimsys UDI Overview

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

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

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

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!

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

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

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