The U.K. MHRA’s newly released framework offers long-awaited clarity by outlining when digital mental health technologies ...

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, ...

Engaging a development partner early provides critical technical and regulatory insight to avoid costly redesigns and ...

Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and ...

PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is ...

Disc pumps enable quieter, smaller, and more precise wearable medical devices, improving patient comfort, measurement accuracy, and system reliability for innovative healthcare solutions.

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...