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How to Build Medical-Device Usability Testing and Validation Into Your Quality System

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Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.

How Does Analytical Testing Improve Food Quality?

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Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal.

FDA’s Ongoing Use of Inspectional Tools During the Covid-19 Pandemic

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During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.

Food Safety Management System Certification Schemes, Highly Effective, But… What a Bunch of Them!

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There are many important issues to be considered in the food industry, such as consumer tastes, environmental impact, and economic aspects, but the most important is food safety.

Medical Laboratory Testing: How Can We Trust the Results?

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Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

Better Data for Use and Safety Profile of Cannabidiol (CBD) Products

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During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis.

How Risk-Based Thinking Could Prevent Thousands of Covid-19 Deaths

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As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19.

Fine-Tuning Remote Audits During Covid-19

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Unlike Covid-19, remote audits aren’t unprecedented. Remote audits didn’t start with the pandemic, although it has forced more companies to use them than previously. At MasterControl, we’ve been doing remote audits for years for our international customers.

Four Essential Processes in Medical Device Risk Management

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Risk can mean many different things depending on the situation. Flying on an airplane, biking on a busy road, driving in a car—all of these involve some level of risk.

Evidence-Based Ergonomic Risk Analysis for Environmental Health and Safety

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About one in two U.S.

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