Global Medical Device Compliance — Reference Books

EU Medical Device Regulation (MDR 2017/745): A Practical Certification Guide

Most medical device companies encounter the EU Medical Device Regulation the way it hurts most: mid-development, with a launch date already promised and a notified body queue longer than anyone budgeted for. This book is built to prevent that collision. It walks through Regulation 2017/745 from first principles to complete practical compliance: whether your product meets the Article 2 device definition and how the twenty two Annex VIII rules classify it, every economic operator role from manufacturer to PRRC, which conformity assessment route applies to your class and what a notified body actually reviews, the General Safety and Performance Requirements and the harmonized standards that satisfy them, building technical documentation and an ISO 13485 quality system that survive real scrutiny, clinical evaluation under the MDR's much stricter equivalence rules, the full testing programme across biocompatibility, electrical safety, software, and usability, software and AI-specific obligations including the EU AI Act overlap, UDI, labeling and EUDAMED including its 2026 mandatory modules, and the post-market surveillance, vigilance, and legacy device transition deadlines running through 2027 and 2028. Every chapter closes with a knowledge check drawn from the companion video course, and eight appendices turn the book's worksheets into templates you can put to work on your own product immediately. This book contains the use of artificial intelligence.

FDA Medical Device Registration & the 510(k) Process: A Practical Guide for Hardware Startups

Most hardware startups building a connected medical device encounter FDA regulation for the first time exactly when it's most expensive to get wrong: mid-development, with a fundraising clock running and a launch date already promised to investors or early customers. This book is built to prevent that collision. It walks through FDA medical device regulation from first principles to complete practical compliance: whether your product actually meets the statutory device definition and how it gets classified, how to choose confidently between the 510(k), De Novo, and PMA pathways, exactly how the 510(k) process runs end to end under the mandatory eSTAR system and the MDUFA review clock, how to build a substantial equivalence argument and select a predicate that survives substantive review, design controls and the Quality Management System Regulation that replaces the old Quality System Regulation in 2026, the real testing programme a device actually needs across biocompatibility, electrical safety, software, and human factors, Section 524B medical device cybersecurity requirements, labeling and the UDI system, establishment registration and current FY2026 fees, and the post-market obligations most teams only discover after their first complaint arrives. Every chapter closes with a knowledge check drawn directly from the companion video course, and eight appendices turn the book's worksheets and checklists into templates you can put to work on your own product immediately. This book contains the use of artificial intelligence.

Medical Device Compliance in India: CDSCO Registration and Import Licensing

Selling a medical device in India requires a CDSCO import licence before the first unit enters the country. The Medical Devices Rules 2017, notified under the Drugs and Cosmetics Act 1940, govern the mandatory premarket licensing of all notified medical device categories — a framework that has expanded substantially since 2017 and continues to grow. Most foreign manufacturers discover the licensing requirement weeks before their intended launch, with none of the groundwork in place. That is the most expensive way to learn. This book is the complete practical guide to CDSCO medical device registration and import licensing for the Indian market. It covers the legal architecture of the framework from the Drugs and Cosmetics Act through the Medical Devices Rules 2017 and their 2020 and 2023 amendments, the four-class risk classification system and how to apply it to any device or in-vitro diagnostic, the Indian Authorized Agent system that serves as the gateway to CDSCO for every foreign manufacturer, the full document dossier required by device class, the SUGAM portal application process from account setup through query management to licence receipt, clinical evidence requirements and the reference country route, manufacturing quality standards under ISO 13485 and Schedule M-III, post-market obligations including adverse event reporting and Field Safety Corrective Actions, labeling requirements under Schedule 7, Software as a Medical Device under CDSCO's 2025 guidance, and the penalty framework for non-compliance. Three end-to-end worked examples, decision trees for every classification question, and a full nine-template compliance toolkit make this a working reference rather than a regulatory summary. The content reflects the Medical Devices Rules 2017 as currently in force, the Class A NSNM exemption introduced in 2023, the CDSCO SaMD guidance published in 2025, and the SUGAM automatic rejection policy in effect from 2026.

Canada Health Canada Medical Device Licensing (Class II–IV)