Understanding the FDA’s thinking and working with the agency is the best way to accelerate compliance. Two important areas in which FDA commonly finds noncompliance issues are in design control and ...

Some may even say that medical device companies are too lax with respect to Design Reviews. Here is a link to an interesting article from Cerulean LLC: “FDA, Experts Weigh in on Industry with ...

ICS' understanding of human-centric design and FDA manufacturing specifications helps medical device and life science organizations navigate regulatory compliance to meet the requirements of ...

WEST CHESTER, Pa.-- (BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access ...