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Overcoming Blockers to Digital Quality Management

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Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done.

How AI Drives Innovation in Healthcare

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Photo by National Cancer Institute on Unsplash

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Artificial intelligence (AI) is revolutionizing the healthcare industry by enhancing decision-making capabilities, improving quality of care, and reducing costs.

How a Purpose-Built eQMS Improves Compliance in Life Science Organizations

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Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance.

Five Foundational Steps of a CAPA Quality Process

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Credit: CDC on Unsplash

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I have a bold opinion: The corrective and preventive action (CAPA) process is the second-most important component of your quality management system (QMS). (If you want to know what I think is No.

IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS Certs

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Credit: IAF CertSearch

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As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices.

Interpreting Data in Context

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In memory of Al Phadt, Ph.D.

Understanding the FDA’s Human Factors Guidance Draft

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Credit: National Cancer Institute on Unsplash.

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On Dec. 9, 2022, the U.S.

Digital Twin Technology: Future of Patient Healthcare

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The healthcare industry is known for rapidly adopting advanced technologies that offer improved treatment for various diseases.

Process Verification vs. Process Validation

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Photo by John Schnobrich on Unsplash.

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In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?

Top Five Challenges for Medical Device Integration

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Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry.

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