Blogs

Introduction Medical device firms trying to innovate while meeting strict regulatory criteria face several quality issues as the industry changes rapidly. As mentioned in (Challenges Q in the 2025 Industry MD), organisations are upgrading their...

Introduction The path from lab to market for a medical gadget is tortuous and full of turns. It begins with research and development, then abruptly enters a maze of regulatory clearances, followed by continual checks...

Introduction The Clinical Evaluation Report (CER) is more than just regulatory paperwork—it helps medical devices enter the EU market. This report describes a device's safety and performance qualities while following high European standards, usually ensuring...