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Book . 2026
License: CC BY
Data sources: Datacite
ZENODO
Book . 2026
License: CC BY
Data sources: Datacite
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Regulatory Compass: Your Guide to Medical Device Laws

Authors: Lahchim, Amal; Khan, Khadija;

Regulatory Compass: Your Guide to Medical Device Laws

Abstract

This book provides a comprehensive and comparative overview of global medical device regulatory frameworks, with a focus on the European Union Medical Device Regulation (EU MDR), the United States Food and Drug Administration (FDA) system, and the regulatory environments of Pakistan and Morocco. Designed for students, engineers, innovators, and policy-oriented readers, the book explores the full lifecycle of medical devices from conception and design to market approval, post-market surveillance, and regulatory compliance. It examines risk classification systems, conformity assessment procedures, quality management standards, and the growing role of emerging technologies such as artificial intelligence and digital health in regulatory oversight. By combining regulatory theory with practical examples and comparative analysis, this work aims to support a deeper understanding of how medical device regulations shape innovation, patient safety, and global market access.

Keywords

Global health regulation, Medical device regulation, Digital health regulation, FDA regulation, EU MDR, Regulatory compliance, Health technology assessment, Biomedical engineering

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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