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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

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Blog Home TAG: Medical device manufacturers

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

In EU MDR, AssurX News + Success Stories, Medical Device Industry, Uncategorized

Posted February 15, 2021

AssurX Webinar – EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

Join us for a one-hour webinar focused on efficient management of postmarket challenges faced by medical device manufacturers marketing devices in the EU. DATE: Tuesday, February [...]

Addressing the EU MDR and IVDR Certification Bottleneck

In EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management

Posted January 19, 2021

Addressing the EU MDR and IVDR Certification Bottleneck

With the May 26, 2021 implementation deadline looming for the new EU Medical Device Regulation (MDR), medical device companies are under pressure to ensure products are compliant with the new [...]

AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers

In Manufacturing Industries, AssurX News + Success Stories, eMDR, Medical Device Industry, FDA Regulated Industries, Regulatory Compliance Management

Posted February 5, 2020

AssurX Releases Manufacturing Incident Report Solution for EU MDR Report Automation for Medical Device Manufacturers

Morgan Hill, CA., February 5, 2020 – AssurX, Inc., a leader in enterprise quality management and regulatory compliance software, announced the availability of its Manufacturing Incident Report [...]

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