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Resource library

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

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RIM Adoption as a Maturity Model
DATA SHEET
RIM Adoption as a Maturity Model
Leveraging Advancements in Regulatory Intelligence and AI for Medtech Success
WEBINAR
Leveraging Advancements in Regulatory Intelligence and AI for Medtech Success
Digital Transformation and the Future of RA Teams
WEBINAR
Digital Transformation and the Future of RA Teams
Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams
WEBINAR
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
WEBINAR
Post-EU MDR Compliance: Key Insights and Activities to Maintain Compliance after Device Certification
Taking SaMDs to market in the US
WEBINAR
Taking SaMDs to market in the US
MDR & IVDR Lessons for Regulatory Strategy
WEBINAR
MDR & IVDR Lessons for Regulatory Strategy
eSTAR submissions overview and live Q&A with FDA
WEBINAR
eSTAR submissions overview and live Q&A with FDA
From planning to acceptance - navigating submissions strategy and FDA market pathways for medical devices
WEBINAR
From planning to acceptance - navigating submissions strategy and FDA market pathways for medical devices
Regulatory AMA: EU MDR Transition Period Extension
WEBINAR
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
DATA SHEET
Medtech quality management systems: an infographic
Optimizing Regulatory Communication
WEBINAR
Optimizing Regulatory Communication
Quality & Regulatory Alignment for Audit Readiness
WEBINAR
Quality & Regulatory Alignment for Audit Readiness
Omron reduces time spent on regulatory reporting by 98%
CASE STUDY
Omron reduces time spent on regulatory reporting by 98%
Regulatory strategy as a competitive advantage
WEBINAR
Regulatory strategy as a competitive advantage
Regulatory Strategy as a Competitive Advantage
EBOOK
Regulatory Strategy as a Competitive Advantage
Exploring the gap between FDA and MDR risk management requirements
WEBINAR
Exploring the gap between FDA and MDR risk management requirements
RAPS Ask an Expert: Everything you wanted to know about UDI
WEBINAR
RAPS Ask an Expert: Everything you wanted to know about UDI
Insights and actions from the 2023 medtech regulatory performance report
WEBINAR
Insights and actions from the 2023 medtech regulatory performance report
The Impact of MDR transition period extensions
WEBINAR
The Impact of MDR transition period extensions
2023 Regulatory performance report
EBOOK
2023 Regulatory performance report
Making the case for a RIM system: an Infographic
DATA SHEET
Making the case for a RIM system: an Infographic
Post-market surveillance for medical devices in the European Union
EBOOK
Post-market surveillance for medical devices in the European Union
Regulatory clearance for medical devices
WEBINAR
Regulatory clearance for medical devices
Regulatory Ask Us Anything: Medical Device submission strategy in China for imported devices
WEBINAR
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
WEBINAR
Actionable regulatory insights and process optimization for MDR/IVDR compliance
Why a regulatory information strategy is critical for successful MDR/IVDR transitions
WEBINAR
Why a regulatory information strategy is critical for successful MDR/IVDR transitions
CE marking guide for medical devices in the EU
EBOOK
CE marking guide for medical devices in the EU
Regulatory AMA - What do you want to know about UDI?
WEBINAR
Regulatory AMA - What do you want to know about UDI?
The ultimate guide to the EU MDR and IVDR general safety and performance requirements (GSPR)
EBOOK
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
EBOOK
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
WEBINAR
Why UDI is a regulatory concern - and not just an operational process
A leading global microbiology manufacturer makes regulatory information instantly accessible
CASE STUDY
A leading global microbiology manufacturer makes regulatory information instantly accessible
RIM for medical devices - challenges and opportunities for automation
WEBINAR
RIM for medical devices - challenges and opportunities for automation
The beginner's guide to the FDA De Novo classification process
EBOOK
The beginner's guide to the FDA De Novo classification process
A medtech imperative: better regulatory information management
WEBINAR
A medtech imperative: better regulatory information management
Global dental adhesives manufacturer reduces essential principles & GSPR maintenance by 99%
CASE STUDY
Global dental adhesives manufacturer reduces essential principles & GSPR maintenance by 99%
The RIM buyer's guide for medtech companies
EBOOK
The RIM buyer's guide for medtech companies
Integrate your regulatory stack for outsized results
WEBINAR
Integrate your regulatory stack for outsized results
The ultimate guide to the medical device single audit program (MDSAP)
EBOOK
The ultimate guide to the medical device single audit program (MDSAP)
The beginner's guide to the FDA 510(k)
EBOOK
The beginner's guide to the FDA 510(k)
Modernizing medtech product registrations
WEBINAR
Modernizing medtech product registrations
The ultimate guide to the China UDI system and database
EBOOK
The ultimate guide to the China UDI system and database
Global digital transformation for medtech regulatory affairs
WEBINAR
Global digital transformation for medtech regulatory affairs
The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System
EBOOK
The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System
A global leader in the in-vitro diagnostics market reduced time spent to create new IVDR GSPRs by 50%
CASE STUDY
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%
CASE STUDY
A global medical device manufacturer reduced release authorization workload by 88%