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Resource library

Free ebooks, research, articles, and videos on global regulatory affairs for medtech

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2023 Regulatory performance report

See insights and process benchmarks for medtech regulatory affairs from a new survey of 200 regulatory professionals across North America and Europe. The report explores regulatory staffing, workload, compliance issues and costs, and the role of technology and digital transformation.

2023 Regulatory performance report

Digital Transformation and the Future of RA Teams

Digital Transformation and the Future of RA Teams

Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams

Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams

Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification

Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification

Taking SaMDs to market in the US

Taking SaMDs to market in the US

MDR & IVDR Lessons for Regulatory Strategy

MDR & IVDR Lessons for Regulatory Strategy

eSTAR submissions overview and live Q&A with FDA

eSTAR submissions overview and live Q&A with FDA

From planning to acceptance - navigating submissions strategy and FDA market pathways for medical devices

From planning to acceptance - navigating submissions strategy and FDA market pathways for medical devices

Regulatory AMA: EU MDR Transition Period Extension

Regulatory AMA: EU MDR Transition Period Extension

An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

Regulatory Brief

An overview of 21 CFR Part 812: Investigational Device Exemptions (IDEs)

Medtech quality management systems: an infographic

Medtech quality management systems: an infographic

Optimizing Regulatory Communication

Optimizing Regulatory Communication

Quality & Regulatory Alignment for Audit Readiness

Quality & Regulatory Alignment for Audit Readiness

Omron reduces time spent on regulatory reporting by 98%

Omron reduces time spent on regulatory reporting by 98%

Regulatory strategy as a competitive advantage

Regulatory strategy as a competitive advantage

Regulatory Strategy as a Competitive Advantage

Regulatory Strategy as a Competitive Advantage

Exploring the gap between FDA and MDR risk management requirements

Exploring the gap between FDA and MDR risk management requirements

RAPS Ask an Expert: Everything you wanted to know about UDI

RAPS Ask an Expert: Everything you wanted to know about UDI

Insights and actions from the 2023 medtech regulatory performance report

Insights and actions from the 2023 medtech regulatory performance report

The Impact of MDR transition period extensions

The Impact of MDR transition period extensions

Making the case for a RIM system: an Infographic

Making the case for a RIM system: an Infographic

Medtech Post-market essentials

Medtech Post-market essentials

Post-market surveillance for medical devices in the European Union

Post-market surveillance for medical devices in the European Union

Regulatory clearance for medical devices

Regulatory clearance for medical devices

Regulatory Ask Us Anything: Medical Device submission strategy in China for imported devices

Regulatory Ask Us Anything: Medical Device submission strategy in China for imported devices

An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

Regulatory Brief

An overview of 21 CFR Part 820 - quality systems for medical device manufacturers

Actionable regulatory insights and process optimization for MDR/IVDR compliance

Actionable regulatory insights and process optimization for MDR/IVDR compliance

Why a regulatory information strategy is critical for successful MDR/IVDR transitions

Why a regulatory information strategy is critical for successful MDR/IVDR transitions

CE marking guide for medical devices in the EU

CE marking guide for medical devices in the EU

Regulatory AMA - What do you want to know about UDI?

Regulatory AMA - What do you want to know about UDI?

RIM readiness checklist

RIM readiness checklist

Introducing Rimsys 5

Introducing Rimsys 5

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)

The beginner's guide to the FDA PMA submission process

The beginner's guide to the FDA PMA submission process

An overview of 21 CFR Part 11 regulations for medical device companies

Regulatory Brief

An overview of 21 CFR Part 11 regulations for medical device companies

Why UDI is a regulatory concern - and not just an operational process

Why UDI is a regulatory concern - and not just an operational process

A leading global microbiology manufacturer makes regulatory information instantly accessible

A leading global microbiology manufacturer makes regulatory information instantly accessible

RIM for medical devices - challenges and opportunities for automation

RIM for medical devices - challenges and opportunities for automation

The beginner's guide to the FDA De Novo classification process

The beginner's guide to the FDA De Novo classification process

A medtech imperative: better regulatory information management

A medtech imperative: better regulatory information management

Global dental adhesives manufacturer reduces essential principles & GSPR maintenance by 99%

Global dental adhesives manufacturer reduces essential principles & GSPR maintenance by 99%

The RIM buyer's guide for medtech companies

The RIM buyer's guide for medtech companies

Integrate your regulatory stack for outsized results

Integrate your regulatory stack for outsized results

The ultimate guide to the medical device single audit program (MDSAP)

The ultimate guide to the medical device single audit program (MDSAP)

The beginner's guide to the FDA 510(k)

The beginner's guide to the FDA 510(k)

Modernizing medtech product registrations

Modernizing medtech product registrations

The ultimate guide to the China UDI system and database

The ultimate guide to the China UDI system and database

Global digital transformation for medtech regulatory affairs

Global digital transformation for medtech regulatory affairs

The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System

The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System

RIM business case template

RIM business case template

A global leader in the in-vitro diagnostics market reduced time spent to create new IVDR GSPRs by 50%

A global leader in the in-vitro diagnostics market reduced time spent to create new IVDR GSPRs by 50%

A global medical device manufacturer reduced release authorization workload by 88%

A global medical device manufacturer reduced release authorization workload by 88%

Rimsys benefits data sheet

Rimsys benefits data sheet