Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fig) provides a st...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Sept 2023
USA | EUROPE | ASIA
USA (FDA) Electronic Submission Template for M...
Small/Mid-size MedTech firms productivity challenge; Lessons learned
Improvements in labor productivity have been the engine of economi...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2023
USA | EUROPE | ASIA
USA (FDA) Informed Consent Guidance for IRBs, ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, July 2023
USA | EUROPE | ASIA
USA (FDA) Medical Device User Fee Rates for Fi...
EO Sterilization; EPA Mandate; Alternates from FDA
In April, the U.S. Environmental Protection Agency proposed limiti...
