BioPharma – USA/Europe/Asia Regulatory Updates, Nov 2023
USA | EUROPE | ASIA
USA FDA Publishes Two Final Guidances on Tech...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Oct 2023
USA | EUROPE | ASIA
USA Guiding Principles on Predetermined Chang...
IVDR Performance Evaluation: An Executive Overview
In vitro diagnostic (IVD) devices are essential component of mode...
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medica...
Post Market Clinical Follow: A Clinical Overview
PMCF defined as a continuous process that are updated in clinical...
Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fig) provides a s...
