Medical Device Manufacturer Archives | Product Lifecycle | AssurX

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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

NERC Compliance Energy & Utilities Industry Regulatory Compliance Management Risk Management

Blog Home TAG: Medical Device Manufacturer

Deviation vs. Nonconformance: What’s the Difference?

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

Posted June 8, 2021

Deviation vs. Nonconformance: What’s the Difference?

Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab workers not following key procedures, leading to contamination of millions of doses. Is this event a deviation or a [...]

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 [...]

EU MDR Compliance Check-in: Challenges and Action Items

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

Posted January 11, 2021

EU MDR Compliance Check-in: Challenges and Action Items

The new EU Medical Device Regulation (MDR) goes into effect in less than six months, leaving little time for medical device manufacturers to bring products into compliance. The new law represents [...]

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