Discover how different levels of management play a role in ensuring quality and how to build a strong quality culture in your organization.
Gain insight into the challenges faced by early-stage life science startups and discover what it takes to succeed in the competitive business.
Manual visual inspection in pharmaceutical manufacturing is a critical process that requires careful risk assessment and mitigation. The FDA and.
Challenges and Considerations in Launching a Medical Device in Multiple Markets. A comparison between EU (MDR) vs. FDA (US Food and Drug.
FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?
The US Breakthrough Device Designation Program can help your company speeding up your Medical Devices development, assessment and review.
MDUFA V is the latest amendment to the to the MDUFA Act, and it could bring an exceptional growth to the MD Community in the US.
