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Month: November 2024

The Role of Predictive Maintenance in Enhancing Medical Device Reliability and Compliance

Predictive maintenance is a game-changing strategy to ensure medical device reliability while maintaining compliance with stringent regulatory standards.

Published November 21, 2024
Categorized as Patrick Gora

Regulatory Challenges of Software as a Medical Device (SaMD): Compliance Best Practices

Staying ahead of regulatory requirements is key to delivering safe, effective, and transformative solutions for patients worldwide.

Published November 21, 2024
Categorized as Patrick Gora of Rochester

EU MDR’s Impact on Startups: Navigating the Regulatory Landscape for Small Manufacturers

Understanding the implications of EU MDR and adopting strategies to meet its requirements is critical for their success.

Published November 21, 2024
Categorized as Patrick John 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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