If you’re in the medical device industry, you may think that design controls are a confusing imposition on your process. They’re a necessary part of your requirements as a medical device developer and ...
Medical device companies have long struggled with understanding design controls and making sure they are implemented correctly to ensure regulatory compliance. Jon Speer Design controls have been a ...
Congratulations! You’ve had a great new idea for a world-changing medical device. You’re about to start the exciting journey of medical device product development. Medical devices aren’t like other ...
We are living in an unprecedented era of rapid medical innovation in the face of COVID-19. The speed of development for devices and diagnostics has been driven by the urgency of the pandemic resulting ...
Dublin, Sept. 22, 2025 (GLOBE NEWSWIRE) -- The "US FDA Medical Device Quality System (QSR) Compliance: Design Controls, Verification & Validation (Oct 27th - Oct 28th, 2025)" training has been added ...
Despite the formidable challenges for developing precision psychiatry, the approach is notching its first successes in the preclinical and even some clinical ...
FDA’s Digital Health Advisory Committee Weighs Guardrails for Generative AI in Mental Health Devices
On November 6, 2025, the U.S. Food and Drug Administration's (FDA) Digital Health Advisory Committee (DHAC) convened for the second time since ...
The External Controls Draft Guidance provides FDA’s thinking specifically with regard to a trial that has a single treatment arm and single control arm. The draft guidance proposes that in addition to ...
(MENAFN- GlobeNewsWire - Nasdaq) Market opportunities include providing training and consulting services to medical device companies for FDA and EU MDR compliance, especially in design controls, ...
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