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

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

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

Accumold secures ISO 13485 recertification, reinforcing its commitment to precision, quality, and reliability in micro molded components for demanding medical device applications worldwide.

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

MedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk ...

Major revisions are coming to the ISO 10993 series, including expected updates to ISO 10993-1 (Biological evaluation) and ISO 10993-3 (Evaluation of genotoxicity, carcinogenicity, reproductive ...

Bringing a new medical device to market is a complex dance that often involves navigating both patent law and regulatory approval. Innovators may find themselves juggling these two worlds: filing ...

Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, ...

Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel ...