Electronic Medical Device Reporting Archives - Quality Management Software + Regulatory Compliance | QMS Software | AssurX

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Opinion: 3 Reasons to Consider SaaS for Quality Management Software

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AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

Elements of a Modern Change Management System

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AssurX BlogQuality, compliance and risk management straight talk for regulated industries.

The Importance of Documenting Enterprise QMS Process Requirements

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NERC Reliability Standards Require Centralized Data Management

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Take Action for ISO 13485:2016 Certification Preparedness

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NERC to Expand CIP Reliability Standards

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Blog Home TAG: Electronic Medical Device Reporting

Medical Device Manufacturers Warned For CAPA Non-Compliance

In Medical Device Industry, FDA Regulated Industries, Quality Management, Regulatory Compliance Management

Posted June 13, 2017

Medical Device Manufacturers Warned For CAPA Non-Compliance

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical device inspection investigative focus. CAPA non-compliance is a top [...]

FDA Warning Letters Emphasize Document Control System Compliance

By Michael Causey

In Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management

Posted April 3, 2017

FDA Warning Letters Emphasize Document Control System Compliance

First quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]

Risk Management + Adverse Event Reporting: FDA Guidance

In eMDR, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management

Posted December 16, 2016

Risk Management + Adverse Event Reporting: FDA Guidance

Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]

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