Medical-Grade Software Development 1st Edition

Grab the attention of engineering teams and healthcare innovators with Medical-Grade Software Development, 1st Edition by Ilkka Juuso and Ilpo Pöyhönen — an essential guide bridging software engineering rigor with clinical safety. This clear, authoritative text anchors complex regulatory and technical topics in practical workflows suited to real-world product development.

Inside, readers will find expertly explained principles of medical device software lifecycle, risk management, verification and validation, and software architecture tailored for safety-critical systems. The authors translate standards such as IEC 62304 and ISO 13485 into actionable practices, and address global regulatory expectations from Europe to North America and beyond, making the book invaluable for teams working across international markets.

Designed for software engineers, quality managers, product owners, and compliance professionals, this edition equips you to build reliable, certifiable healthcare software. Case studies and pragmatic checklists help you avoid common pitfalls, streamline documentation, and align development with clinical and regulatory requirements — reducing time-to-market while maintaining patient safety.

Whether you’re developing embedded device firmware, clinical decision support tools, or cloud-based medical applications, this book offers a professional roadmap to produce robust, audit-ready software. Practical, readable, and thoroughly up-to-date, Medical-Grade Software Development is the reference every health-tech team needs to turn regulatory complexity into competitive advantage. Secure your copy today and lead safer, compliant innovation in healthcare technology.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.