European Authorized Representative Under MDR/IVDR: IGJ Inspection
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Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
According to the EU MDR, post-market surveillance (PMS) is the “proactive,…
Prioritizing Device Regulatory Approval: FDA Approval or CE Mark
With a projected revenue in 2024 of US $182 billion and an estimated annual growth rate of 5.49% (CAGR…
What is MDSAP and How to Prepare for Your MDSAP Audit
The Medical Device Single Audit Program (MDSAP) is a framework that streamlines the quality system audit process for device…
CDSCO Medical Device Grouping Structure in India
All medical devices being imported into India need to be registered with the government body called the Central Drugs…
What is Substantial Equivalence Under the FDA?
The concept of ‘substantial equivalence’ is the foundation of the US…
TGA UDI System: What Manufacturers Must Know for Compliance
The Therapeutic Goods Administration (TGA) Unique Device Identification (UDI) system has been in development for several years with several…
QSR vs. QMSR: FDA’s New Quality System Requirements
On February 2, 2024, US FDA published the final rule harmonizing its quality system requirements to…
Common Mistakes When Undergoing MDR Notified Body Agreements
The revised transitional provisions of the MDR allow for the following devices to be placed on…
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