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The Food Safety Modernization Act in a Nutshell

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According to information from the Centers for Disease Control and Prevention (CDC), every year 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die from

Life Without the Paris Agreement

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How will the United States’ withdrawal from the Paris Agreement affect greenhouse gas emissions?

Why Audits Are the Way Forward for AI Governance

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Much has been written about the challenges associated with AI-based decisions.

How to Use Gamification Principles to Boost Audit Participation

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When Deloitte wanted to get people excited about employee training, the company decided to adopt a gamification strategy for its online training portal.

Implementing ISO 13485

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Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices.

The Transformative Impact of Standardization

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In manufacturing, standardization in production and process control leads to increased profitability and cuts down on many siloed problems that can plague even the most quality-focused organization.

IATF 16949 Adds Value to ISO 9001:2015

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The martial arts rank, Shodan, for a first-degree black belt, does not mean “expert”; it means “first step.” ISO 9001:2015 is similarly a valuable and vital first step toward world-class performance, but it is only that—a first step.

Global Regulatory Harmonization

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Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation.

Shape a New Future With ISO’s Innovation Management Standards

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Innovation isn’t just about having a few bright ideas. It’s about creating value and helping organizations continuously adapt and evolve.

FDA to Sunset Alternative Summary Reporting Program

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The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

Pagination

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