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 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, ...

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

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

In recent years, software has been playing an increasingly critical role in the medical device world. Software with a medical intended use can be embedded as part of a medical device (and regulated as ...