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…
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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…
Swiss Medtech Guidance Document for Legacy Devices Compliance
Swiss Medtech released a guidance document tailored for economic operators in Switzerland. It delineates the necessary steps for…
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…
New MDCG Guidance on Investigator’s Brochure for Medical Device Trials
The Medical Device Coordination Group (MDCG) is active this month, releasing a new guidance document. This latest guidance focuses…
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…
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