Medical Device Risk Management for Device Manufacturers
Like other types of therapeutic products, risk is…
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Understanding TGA Application Audits for ARTG Inclusion
While not all applications for inclusion of a device on the Australian Register of Therapeutic Goods (ARTG) are subject…
Software as a Medical Device (SaMD) EU MDR Compliance
Navigating the realm of Software as a Medical Device (SaMD) within the EU Medical Device Regulation (MDR) can be a…
European Authorized Representative Under MDR/IVDR: IGJ Inspection
The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards.
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…
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