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.

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

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 ...

Discover Accumold’s micro molding expertise at COMPAMED 2025, where ultra-precision, scalability, and DfMM capabilities showcase how next-generation medical devices are enabled through unmatched ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

What if a single symbol on your medical device label could determine market access — or trigger compliance gaps across jurisdictions? The recent update to ISO 15223-1 — formalized through Amendment ...