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

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 ...

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.” Over 25 years leading global ...

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 ...

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

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 ...

Anyone who has been doing risk management for medical devices or combination products is familiar with the ISO 14971:2019 and ISO/TR 24971:2020 standards. These recognized standards describe a risk ...

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 ...

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 ...

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