Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for ...

STEMart announces the expansion of its genetic toxicology capabilities with the In Vivo Rat Micronucleus Test services.

Medical device rapid prototyping cuts development delays by 40% despite talent shortages. Achieve ISO 13485 compliance and faster iteration cycles. The medical device industry is navigating a perfect ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Syensqo debuts Eviva PSU stock shapes and partners with MedTech Innovator to accelerate medical device development and ...

PERFI Technologies is redefining medical 3D printing with VAM, enabling fast, personalized audiology and dental devices.

Compliance is one of the most persistent bottlenecks in regulated software development, often requiring weeks or months of manual documentation after products are built. In this episode of DEMO, Keith ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Hands-on research and applied technology experiences prepare University of New Haven students for careers in high-demand innovation sectors. The University of New Haven has entered into a master ...

Additive manufacturing (AM) has become a powerful tool for accelerating regulated medical device development. Yet its value hinges on how and when it’s applied. At the MD&M show in Anaheim, CA, Carl ...

Anyone who has worked inside a MedTech organization knows that bringing a new device to market is not a single sprint. It is a marathon made up of dozens of short, fast, sometimes messy races — market ...