Resource library

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

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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)
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
BISCO reduces essential principles & GSPR maintenance by 99%
CASE STUDY
BISCO 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%