Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...

LIMERICK, Ireland, Jan. 06, 2026 (GLOBE NEWSWIRE) -- kneat.com, inc. (TSX: KSI) (OTCQX: KSIOF), the global leader in digital validation and quality process automation, today announced a Master ...

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product ...

Kneat's SaaS model automates validation processes in pharma and biotech, reducing errors and ensuring compliance. KSIOF's gross margins have expanded to 75% by 2024, nearing EBITDA profitability with ...

As the Artemis I uncrewed moon-orbiting mission comes to a successful end, LDRA – the project’s software verification, source code analysis, and testing partner – reiterated its ongoing support in the ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...