Successful document control in medical device and pharmaceutical companies hinges on understanding the audience and involving all relevant stakeholders in document creation and review. Maintaining
After acquiring another company, MedTech and pharmaceutical manufacturers should carefully evaluate and harmonize quality management systems by blending the best practices from each to build
The FDA has updated its finalized pre-market cybersecurity guidance for medical devices by adding a new section on cyber devices and removing the “hardening” definition,
The FDA is integrating generative AI into its product review process to streamline repetitive tasks, improve consistency, and accelerate innovation. An expert urges MedTech and
The FDA’s rollout of generative AI aims to streamline drug and device reviews, but experts warn of risks like algorithmic bias and “AI poisoning” that
In this post, you’ll hear from our newest Consulting Director, Rebecca Fuller. With more than 30 years of industry experience, we wanted to get her