It’s an iterative process because risk never disappears, and products must continuously evolve to new standards.

Able Medical Devices, a Marquette-based medical device manufacturer, is expanding its operations in Michigan’s Upper ...

DCGI is planning to amend the Medical Devices Rules, 2017 to include a provision for quality requirement for non-sterile and ...

Recalled heart devices often do not go through clinical testing, a new study found, highlighting growing concerns about the ...

Outsourcing your medical device manufacturing with a trusted, experienced partner can increase efficiency and reduce supply ...

VitalPath Global Sales VP Nichole Ramus was previously at Vantedge Medical, Heraeus Medevio and Quality Tech Services (Cretex ...

India’s apex drug regulator is collating information on adverse events due to medical devices to take timely action against ...

The Drugs Technical Advisory Board (DTAB) has approved a proposal to amend Rules 19H and 19J of Chapter IIIB of the Medical ...

The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms.

The voluntary scheme, launched officially on Oct 16, will rate the devices according to their level of cyber-security ...

Findings from a new survey of executives in MedTech companies reveal that the majority of their revenues come through contracts with healthcare facilities, integrated delivery networks (IDNs) and ...

Gov. Glenn Youngkin said the project strengthens Virginia’s reputation as a hub for innovative medical technology solutions.