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 ...
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.
In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...
The Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document on the conduct and regulation of Medical Device Software (MDSW) under the Medical Devices Rules (MDR), ...
FDA finds widespread quality issues at three Philips medical device facilities, citing violations in manufacturing and complaint handling.
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