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 ...

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 ...

Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...

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.

Search for requirements management tools for medical device development and you’ll find plenty of content arguing that the established platforms are too heavy for modern teams. Much of it comes 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 ...

Don’t build your medical device software for the regulatory submission—build it for long-term product success.