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Shifting Auditor Competency in the Supply Chain: The Impact of New IAF MD9:2022

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February 15, 2022, 12:03 pm

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Risk Management for Medical Devices

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September 2, 2021, 12:02 pm

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Closed-Loop Traceability for FDA Compliance

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June 2, 2021, 12:01 pm

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More Must Be Done to Promote IAF CertSearch

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January 27, 2021, 12:02 pm

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Unannounced Audits

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November 18, 2020, 12:02 pm

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IEC 60601-1:2020 Edition 3.2 Launches. Prepare for Impact!

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November 3, 2020, 12:03 pm

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This Time, It’s Not All China’s Fault

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May 28, 2020, 12:03 pm

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Possible Cure for Outbreak of Fake Certificates From Covid-19 Pandemic

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May 28, 2020, 12:01 pm

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Three Myths Engineers Believe About Quality

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April 1, 2020, 12:02 pm

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FDA Form 483 Observations and Warning Letters: What’s the Difference?

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March 11, 2020, 12:03 pm

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Quality Is Everything

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December 24, 2019, 12:03 pm

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Five Tips From Medtech Executives on the Value of Quality

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October 22, 2019, 12:02 pm

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Qualifying Your Suppliers Using a Risk-Based Approach

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June 13, 2019, 12:02 pm

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What to Expect During an FDA QSIT Inspection

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March 19, 2019, 12:03 pm

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MDSAP: When Is a Certificate Not a Certificate?

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September 12, 2018, 12:00 pm

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Investing in Advanced Domestic Drug Manufacturing

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August 7, 2018, 12:03 pm

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Why the FDA Presubmission Is an Underutilized Tool

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April 30, 2018, 12:03 pm

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How to Integrate Complaint Handling and Risk Management

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January 30, 2018, 12:02 pm

Let technology help Content Marketing off In Rotator:  off CM Scroll:  off read more

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Some of the FDA’s Major Policy Goals for 2018

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January 16, 2018, 12:01 pm

A year of advancing innovations, empowering consumers, and streamlining regulations Content Marketing off CM Scroll:  off read more

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What a Risk-Based QMS Means

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November 27, 2017, 12:02 pm

And how it relates to four critical concerns What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management...

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