Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and customization are overcoming industry challenges for better patient outcomes ...
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, ...
Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.
MedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk ...
Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel ...
Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, ...
The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. We've mastered ISO 13485, understood CFR 820, and navigated EU MDR ...
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