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

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

Amendment Rules, 2025, aligning medical device packaging norms with the 2017 rules to simplify labelling, ease compliance, ...

In a significant regulatory move aimed at harmonizing labelling standards and reducing compliance overlap, the Department of ...

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, ...

The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), ...

New agreement grants Terumo Virtue SAB coronary indication right of first refusal and supersedes prior distribution agreementTerumo to pay a ...

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

The U.S. Food and Drug Administration (FDA) has sent Royal Philips CEO Roy Jakobs a warning letter saying the devices made at three of its facilities are adulterated and fail to conform ...

Highlights† Reported revenue of $384.2 million, up 13.0%Constant currency revenue* and constant currency revenue, organic* up 12.5% and up 7.8%, ...

Healthcare Holding Schweiz AG, a leading provider of medical technology services and distribution solutions in Switzerland, has expanded its portfolio through the acquisition of a stake in QUNIQUE ...

The FDA has sent Philips a warning letter over three ultrasound and enterprise informatics facilities in the U.S. and the Netherlands.