Power plants are engineered with precision down to the smallest detail, yet one critical variable is often considered too ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

FLO, offers practical guidance on leveraging artificial intelligence, digital twins and streamlined workflows to improve ...

Perhaps the most important message of the guidance is implied, rather than stated. By explicitly emphasizing the use of risk-benefit determinations in the product approval process (even if for a ...

Overview: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...

Participate in our immersive 2-day virtual seminar to acquire essential knowledge and establish robust processes for Design Controls in the production of safe and effective medical devices. Recognized ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Design Control Essentials Course" training has been added to ResearchAndMarkets.com's offering. Participate in our immersive 2-day virtual seminar to ...