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5 Key Elements of an Effective CAPA System

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The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS).

Your Organization’s Culture Might Be Sick, But You Can Heal It

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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?”

Why QMS Software Is No Longer Optional in Regulated Industries

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Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages.

One Simple Question That Keeps You From Falling on Your Sword

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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.

How Tech-Enabled Solutions Can Simplify BRCGS Packaging Materials

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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

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As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S.

Finding Your Daily Motivation

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I heard an interesting twist on an old question the other day. People always ask the classic, “What keeps you up at night?” question. (By the way—don’t ever ask that of your interviewer during a job interview.

Accountable When AI Fails?

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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.

Learning How to Predict Rare Kinds of Failures

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On Dec. 21, 2022, just as peak holiday season travel was getting underway, Southwest Airlines went through a cascading series of failures in its scheduling, initially triggered by severe winter weather in the Denver area.

Strong QMS Is Central to the Med Device Right-to-Repair Movement

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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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