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 ...
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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
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 ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
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 ...
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 ...
AI transforms vehicle engineering by automating complex integration tasks and enabling continuous software evolution ...
General Motors is sliding into a quagmire of software issues. Having previously issued a stop sale of its brand-new Chevy Blazer electric SUV over related concerns, it is now holding back deliveries ...
DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...
A recent change in outlook at the U.S. Food and Drug Administration (FDA) — the government body that regulates the use of devices and substances in medical care — has escalated the already rigorous ...
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