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Don’t take your foot off the gas on EU MDR implementation

The coronavirus has had a massive impact on the medical device industry.  As a consequence, the European Commission has accepted a proposal to postpone the EU MDR application date. This may be a [...]

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The Six C’s of a Modern Complaint Management System 2020

Regulators such as FDA, European Commission (EC), ISO 13485  require a product complaint management system that is effective for resolving product quality issues and improving patient safety. [...]

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Human Error is a Precipitator for Root Cause Analysis, Not Blame

Have you ever been part of a process that had a failure or two? Perhaps you’ve been on a team that missed a deadline because something didn’t go as expected.  Most of us have. In many cases, the [...]

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