Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will ...

Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of ...

Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy ...

Consulting and engineering services are available to help meet regulatory requirements for building materials in both Canada and the United States (ICBO & CABO) as applicable... ETL SEMKO, a division ...

All startups must navigate the “Valley of Death” as they transition from initial discovery and ideation to market launch. This critical period, characterized by heightened risk of failure, is ...

Occlusion testing using robotic automation for medical devices, such as infusion pumps, catheters, IV lines, insulin pumps, ventilators, and other drug delivery systems, involves robotic systems to ...

Growing up in a family deeply rooted in medicine, I had a unique perspective on the field. My grandparents attended Meharry Medical College, and my parents met while studying at Howard University ...

Smart implants, embedded with sensors, represent the future of healthcare by enabling real-time monitoring and response capabilities. These devices include pacemakers, neurostimulators, and orthopedic ...

The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It ...

The deadline for medical devices compliance to the new medical devices regulation 2017/745 (EU MDR) was originally May 2020 for class l non-sterile devices and May 2024 for all other devices. During ...

The Journal of Validation Technology is a peer reviewed journal exclusively dedicated to providing practical approaches to conducting effective validations Institute of Validation Technology of ...