Author: Practical RA Original

  • What Is Regulatory Affairs in Medical Devices: The Ultimate No Nonsense Guide

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    Practical RA Original
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    Introduction In the complex world of medical device development and commercialization, regulatory affairs plays a pivotal role in ensuring products are safe, effective, and compliant with global requirements. What is regulatory affairs in the medical device industry? At its core, regulatory affairs is the profession responsible for navigating the intricate web of regulations governing medical…

  • FDA eSTAR: Navigating the New Era of Medical Device Submissions

    FDA eSTAR: Navigating the New Era of Medical Device Submissions

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    Practical RA Original
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    Introduction To The FDA eSTAR Program The medical device industry is witnessing a significant transformation in regulatory affairs, particularly in how manufacturers submit their applications to the US Food and Drug Administration (FDA). The Electronic Submission Template And Resource (eSTAR) program represents the FDA’s commitment to modernizing the review process for medical devices, moving away…

  • Leveraging Approvals and Market Access with CE-Marking

    Leveraging Approvals and Market Access with CE-Marking

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    Practical RA Original
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    Leveraging EU MDR CE Marking for Global Medical Device Market Access A comprehensive guide to maximizing your regulatory strategy through EU MDR compliance Introduction Navigating the complex landscape of medical device regulatory affairs can be challenging for manufacturers seeking global market access. While many companies view regulatory compliance as merely a hurdle to overcome, strategic…

  • Technical documentation under the EU MDR

    Technical documentation under the EU MDR

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    The Evolving Landscape of European Medical Device Regulatory Affairs: Navigating EU MDR 2017/745 Requirements For professionals in regulatory affairs or innovative MedTech companies, understanding the European Medical Device Regulation (MDR 2017/745) represents a critical competency in today’s global healthcare market. The implementation of the EU MDR marked a significant shift from the previous Medical Device…