Blogs
Real World Evidence in Medical Device…
Real-world evidence (RWE) refers to data regarding the use, effectiveness, and safety of medical prod…
Medical Devices – USA, Europe, Asia a…
USA
FDA Data Standards Catalog Version 10.3
The FDA Data Standards Catalog listed the sub…
Consumer Health – USA/Europe/Asia/ROW…
USA
New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry
FDA …
Consumer Health – USA/Europe/Asia/ROW…
USA
FSIS Guideline for Label Approval
This guideline is designed to help establishments deter…
Pharma/Biotech – USA, Europe, Asia an…
USA
Three FDA Final Guidance’s on Electronic Submission of Safety Reports
Three FDA final gui…
Adopting a Life Cycle Approach to Sof…
In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach”…
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