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Month: July 2024

Implementing Effective Quality Systems Under EU Medical Device Regulation (EU MDR)

The essential components of a compliant quality system, and practical tips for aligning existing quality systems with the new requirements to ensure ongoing compliance.

Published July 23, 2024
Categorized as Uncategorized

The Impact of EU Medical Device Regulation (EU MDR) on the Industry

We delve into the EU MDR, its key provisions, the timeline for implementation, and the challenges and opportunities it presents for the medical device industry.

Published July 23, 2024
Categorized as Patrick Gora

Recent Posts

  • Design Verification vs. Design Validation: Key Differences and Best Practices
  • Key Steps for Building a Robust Quality Management System (QMS) from Scratch
  • Patient-Centric Design in Medical Devices: A Regulatory Perspective
  • Digital Health Trends: Regulatory Insights for Remote Monitoring Devices
  • The Role of Predictive Maintenance in Enhancing Medical Device Reliability and Compliance

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