Life Science Regulatory Compliance Archives | QMS

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

Opinion: 3 Reasons to Consider SaaS for Quality Management Software

Medical Device Industry FDA Regulated Industries Pharmaceutical Industry Quality Management Regulatory Compliance Management

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

The Importance of Documenting Enterprise QMS Process Requirements

Energy & Utilities Industry FDA Regulated Industries Regulatory Compliance Management

NERC Reliability Standards Require Centralized Data Management

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management

Take Action for ISO 13485:2016 Certification Preparedness

FDA Regulated Industries Regulatory Compliance Management Risk Management

NERC to Expand CIP Reliability Standards

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management Risk Management

Blog Home TAG: Life Science Regulatory Compliance

EU MDR Compliance: An Opportunity for Change

By Heather Thompson

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

Posted August 15, 2019

EU MDR Compliance: An Opportunity for Change

EU MDR Compliance: The new European device regulation will bring about impactful change. It is designed to do so. Since the 1990s, medical device regulation in Europe has been relatively [...]

Risk Management + Adverse Event Reporting: FDA Guidance

By AssurX

In Archives, 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 new FDA guidance. Producing and controlling electronic records will be critical to [...]

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