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 Understanding FDA Alignment of ISO 13485 with Quality System Regulation
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Understanding FDA Alignment of ISO 13485 with Quality System Regulation

The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve [...]

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 miraDry Implements AssurX Quality Management and Regulatory Compliance Software
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In Manufacturing Industries, Complaint Management, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management
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miraDry Implements AssurX Quality Management and Regulatory Compliance Software

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader in quality management software and regulatory compliance software, announced today that miraDry®, a leading [...]

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 How an EQMS can Reduce CAPA and Complaint Observation Trends
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In Manufacturing Industries, Food & Beverage Industry, Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management
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How an EQMS can Reduce CAPA and Complaint Observation Trends

As we move through 2022, we look forward to new opportunities, new challenges, and a return to normal. Unfortunately, one thing that won’t change is the likelihood of FDA CAPA and complaint [...]

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