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

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

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

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

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

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

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

Discover from Leibowitz Law how to embed compliance and contractual protections into your wearable device contracts from the ...

Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to ...

Bowie-Dick testing is essential for compliance, but the choice between disposable and reusable systems impacts cost, waste, ...