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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

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NERC to Expand CIP Reliability Standards

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Blog Home TAG: MDR

All Roads Lead to ISO 13485: The Global Context

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

Posted May 5, 2021

All Roads Lead to ISO 13485: The Global Context

As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for streamlining [...]

EU MDR Countdown: What’s Next for Medical Device Compliance

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

Posted January 21, 2021

EU MDR Countdown: What’s Next for Medical Device Compliance

In four months, the new EU Medical Device Regulation (MDR) goes into effect, which officially means it’s crunch time for devices that need to be certified to the new law. What should companies be [...]

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 [...]

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