Insights

Deepak Bharrgava The medical device industry is undergoing a profound transformation driven by advances in artificial intelligence. Among the most promising developments are generative and agentic AI technologies, which are reshaping how medical devices are designed, developed, and deployed. These AI systems offer new ways to create personalized solutions, improve diagnostics, and automate complex tasks, pushing the boundaries of what medical devices can achieve. This post ex

Obtaining Forest Stewardship Council (FSC) certification is becoming increasingly important for manufacturers of in vitro diagnostic (IVD) and medical devices who rely on paper packaging from suppliers. This certification ensures that the paper materials used come from responsibly managed forests, supporting environmental sustainability and meeting growing regulatory and market demands. This post explores the key steps, challenges, and benefits of securing FSC certification f

Deviations in medical device manufacturing and quality management are inevitable. How organizations handle these deviations can make the difference between compliance success and costly regulatory setbacks. This post explores practical strategies for managing deviations under ISO 13485, the European Union Medical Device Regulation (EUMDR 2017/745), IMDR-2017, and 21 CFR 820. Understanding these frameworks and applying effective deviation handling processes ensures product saf