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 ...

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 ...

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 ...

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 ...

If you are developing a medical device for the U.S. market, you first need to determine how your device will be classified by FDA. If you do not know the FDA classification, I recommend you go check ...

(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, ...

Despite the formidable challenges for developing precision psychiatry, the approach is notching its first successes in the preclinical and even some clinical ...

The Food and Drug Administration last week released long-awaited recommendations aimed at better managing cybersecurity risks to protect patient health and information. The new recommendations are ...