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

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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: Medical Device Manufacturer

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 [...]

How to Meet New EU MDR Requirements for Vigilance and Reporting

In Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management

Posted December 3, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting

After a one-year delay due to concerns over a shortage of notified bodies, the new EU Medical Device Regulation (MDR) is set to take effect as of May 26, 2021. The regulations are a departure [...]

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