The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...

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 ...

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 ...

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

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

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 ...

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 ...

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 ...

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