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 ...

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 ...

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 ...

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

A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...