Training
The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and…
Most days we walk through life unaware of the conversations occurring around us. And then there are those times you overhear a conversation that stops you dead in your tracks. You have to hit rewind in your brain and ask, “Did they actually just say that?”
Ever have one of those…
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and ultimately losing competitive ground.
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I love passionate people—people who throw themselves into their work with every last bit of energy they have. To them, everything about their work is important. It’s serious business, and they drive hard to form the world in an image they’re proud of.
However, with passion comes…
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, consumer products, and retail. It aims to ensure that businesses maintain high standards of safety and quality…
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF):
• “AI-enabled…
