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How to Manage Regulatory and Quality Risks in Medical Device Projects

Let’s outline strategies for managing regulatory and quality risks to ensure project success and compliance.

Published January 30, 2025
Categorized as Patrick Gora

Common Reasons for Delays in Regulatory Submissions and How to Overcome Them

Understanding the common reasons for delays and adopting strategies to mitigate them can help organizations streamline their processes and achieve timely approvals.

Published November 21, 2024
Categorized as Patrick Gora

The Role of Human Factors Engineering in Medical Device Design and Regulatory Compliance

Let’s explore the importance of human factors engineering in medical device design and its role in meeting regulatory requirements.

Published October 23, 2024
Categorized as Patrick Gora

Supply Chain Management in Medical Device Manufacturing: Ensuring Quality and Compliance

We explore the essential strategies and practices involved in managing suppliers, ensuring traceability of components, and mitigating risks associated with supply chain disruptions in the medical device industry.

Published July 23, 2024
Categorized as Patrick Gora

Recent Posts

  • Challenges of Conducting Clinical Investigations for Medical Devices Under EU MDR
  • How AI is Changing the Future of Pharmacovigilance: Regulatory Implications
  • The Role of Companion Diagnostics in Precision Medicine: Regulatory Challenges and Market Trends
  • Essential Components of a Strong Regulatory Dossier for Medical Devices
  • How to Manage Regulatory and Quality Risks in Medical Device Projects

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