Regulatory Compass: Your Guide to Medical Device Laws
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| Autori principali: | , |
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| Natura: | Recurso digital |
| Lingua: | inglese |
| Pubblicazione: |
Zenodo
2026
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| _version_ | 1866902124328124416 |
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| author | Lahchim, Amal Khan, Khadija |
| author_facet | Lahchim, Amal Khan, Khadija |
| contents | <p>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. </p> <p>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.</p> <p>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.</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_18505588 |
| institution | Zenodo |
| language | eng |
| publishDate | 2026 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Regulatory Compass: Your Guide to Medical Device Laws Lahchim, Amal Khan, Khadija Medical device regulation EU MDR FDA regulation Global health regulation Digital health regulation Regulatory compliance Biomedical engineering Health technology assessment <p>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. </p> <p>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.</p> <p>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.</p> |
| title | Regulatory Compass: Your Guide to Medical Device Laws |
| topic | Medical device regulation EU MDR FDA regulation Global health regulation Digital health regulation Regulatory compliance Biomedical engineering Health technology assessment |
| url | https://doi.org/10.5281/zenodo.18505588 |