As the FDA prepares to retire its longstanding Quality System Inspection Technique with the rollout of the new Quality Management System Regulation, QSIT creator and
The FDA’s Quality Management System Regulation, effective Feb. 2, replaces the agency’s traditional Design Controls with ISO 13485–aligned Design and Development activities, marking a significant
With the FDA’s Quality Management System Regulation coming into force on Feb. 2, medical device makers face heightened pressure to strengthen risk management practices as
Five FDA officials answer questions from medical device manufacturers about the agency’s Quality Management System Regulation, or QMSR, which goes into force for industry on
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