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MedTech

Regulatory should be a revenue function
Regulatory should be a revenue function
Ask us Anything ... about China submissions!
Ask us Anything ... about China submissions!
IMDRF: International Medical Device Regulatory Forum
IMDRF: International Medical Device Regulatory Forum
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?
FDA Class II medical devices
FDA Class II medical devices
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
Ask us Anything ... about UDI!
Ask us Anything ... about UDI!
CE marking guide for medical devices in the European Union
CE marking guide for medical devices in the European Union
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
ISO 14971: risk management for medical device manufacturers
ISO 14971: risk management for medical device manufacturers
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
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
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
MDSAP - the ultimate guide to the medical device single audit program
MDSAP - the ultimate guide to the medical device single audit program
The ultimate guide to the China NMPA UDI system and database
The ultimate guide to the China NMPA UDI system and database
FDA 510(k) - a beginner's guide
FDA 510(k) - a beginner's guide
A primer on medical device classification
A primer on medical device classification
EUDAMED and UDI in Europe: an overview
EUDAMED and UDI in Europe: an overview
The ultimate guide to the EU MDR/IVDR UDI
The ultimate guide to the EU MDR/IVDR UDI
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)
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?
Quick reference guide - global medical device UDI requirements and timelines
Quick reference guide - global medical device UDI requirements and timelines
The 510(k) application: if content is king, then communication is queen
The 510(k) application: if content is king, then communication is queen
Is a medical device accessory a medical device?
Is a medical device accessory a medical device?
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process
Podcast – Streamlining the MDSAP device marketing authorization and facility registration process
MDSAP device marketing authorization and facility registration
MDSAP device marketing authorization and facility registration