5 Key Elements of an Effective CAPA System
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS).
Why QMS Software Is No Longer Optional in Regulated Industries
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages.
Transforming Audits With AI
For quality heads, compliance officers, auditors, and engineering leaders, audits have been a time-consuming, resource-intensive process, yet necessary to build resilient operations, prevent costly failures, and maintain competitive advantage.
The Ethics of Choice
In this article I’m exploring the need for ethics in systems thinking using the ideas of Heinz von Foerster and Russell Ackoff. The two come from different traditions within systems thinking.
Why Forcing Women Back to the Office Will Cost Us Millions
As companies and government agencies push forward with return-to-office (RTO) mandates, they risk exacerbating a workplace problem that many have failed to address adequately: gender discrimination.
How Tech-Enabled Solutions Can Simplify BRCGS Packaging Materials
A global food safety and quality certification, BRCGS (British Retail Consortium Global Standards) initially focused on food safety but now comprises various sectors such as packaging, co
FDA Guidances on AI-Enabled Devices
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S.
Accountable When AI Fails?
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
Strong QMS Is Central to the Med Device Right-to-Repair Movement
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option.
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