FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR requirements govern “the methods used ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it's a legitimate engineering discipline with specific, defensible use cases: replacing ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

3 January 2024 - Sanner Group, a leading global healthcare packaging manufacturer and medical device Contract Development and Manufacturing Organisation (CDMO) has acquired Springboard, a specialist ...

Learn why building cybersecurity into medical devices early can reduce risks, strengthen patient safety, support compliance, and avoid costly security fixes later.

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

Understanding the lengthy timeline for product development better equips manufacturers for responding to faulty cleaners and disinfectants. It can take three to seven years before a medical product ...