Medical device makers use AI to turn EU regulatory challenges into competitive advantages via supply chain optimization.

Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding ...

Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...

Specialized outsourcing partners bring in the technical depth and regulatory knowledge required to navigate the complex medical device lifecycle efficiently. The growing global demand for innovative, ...

Learn what the recently released CDSCO draft guidelines for medical device software within India actually mean.

The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), ...

LITTLETON, Colo.--(BUSINESS WIRE)--Pico-Tesla, The Magneceutical ® Company, has received the International Organization for Standardization (ISO) 13485:2003 certificate for the “design, development, ...

FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.

Toronto, Ontario--(Newsfile Corp. - December 14, 2023) - NuGen Medical Devices Inc. (TSXV: NGMD) (the "Company" or "NuGen") a leading developer of needle-free devices to administer therapeutics ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug ...