FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 ...

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

In a year characterized by both unprecedented challenges and groundbreaking advancements, the medtech industry continues to demonstrate its resilience and capacity for innovation. Faced with the ...

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 ...

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 ...

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 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 ...

Both the BTC IIS and TTC IIS Series by Parker Hannifin comprise brush and brushless DC motor driven pumps ideal for medical applications such as anesthesia monitors, CO2 monitors, wound therapy, ...

The European medical device industry is in the grip of the biggest changes the market has seen in decades. Significant new rules to ensure the safety of medical devices became active in June 2017, ...