Engineering High Quality Medical Software

Master the world of medical software engineering with Antonio Coronato's detailed exploration of regulations and standards. This book provides a comprehensive understanding of crucial frameworks like ISO 13485 and IEC 62304, essential for developers aiming to excel in this field. With a focus on risk management and prescriptive software development life cycles, it is an invaluable resource for professionals seeking to ensure compliance and quality.

What You'll Learn

• Navigate EU MDD 93/42/EEC regulations
• Apply FDA title 21 of US CFR to software
• Implement ISO 13485 quality management systems
• Engage with IEC 62304 software life-cycle processes
• Conduct effective static and dynamic testing

Who This Book Is For

This book is ideal for software engineers and project managers working in the medical device sector, as well as compliance officers seeking to understand regulatory frameworks. Aimed at those with some experience in software development and regulatory environments.

What You Need to Know First

Readers should have a basic understanding of software development processes and familiarity with general quality management principles. Prior experience in medical device software is beneficial but not required.

Why This Book

Antonio Coronato's book stands out for its structured approach to integrating regulations with practical software development. Unlike other texts, it offers a clear roadmap from regulatory theory to application, focusing on specific standards rather than generic advice.

What's Inside

Authored by Antonio Coronato, this 297-page book features 20 chapters covering all facets of medical software engineering, from introductory concepts to detailed regulatory insights. Published by The Institution of Engineering and Technology, it is an authoritative resource for industry professionals.