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…
MHRA’s AI Airlock Pilot Project Revolutionizing AI Medical Device Regulation
The MHRA have started a pilot project in response to a white paper published in 2023…
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…
IMDRF Updates Labeling Guidelines for Medical Devices & IVDs
We’re excited to share the latest update to the IMDRF’s labeling guidelines for medical devices and IVDs. The IMDRF/GRRP WG/N52…
What is Substantial Equivalence Under the FDA?
The concept of ‘substantial equivalence’ is the foundation of the US…
MDCG Guidance: Safety Reporting in Performance Studies
There is a new IVDR MDCG guidance published MDCG 2024-4 Safety Reporting in performance studies of in vitro diagnostic medical…
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