Keys to medical compliance

ISBN-13: 9786209435508 / Angielski / Miękka / 2025 / 100 str.

CHERIF GHEBACHE

Opis

Summary - Volume IKeys to medical compliance: from idea to global market launch is a concise, accessible guide to understanding how a medical innovation becomes a safe, high-performance device that complies with international requirements.The book presents the key standards - ISO 13485, ISO 14971, ISO 10993, GMP, MDR/IVDR, FDA, IEC 60601, ISO/ASTM 52900 - and explains their role in quality, risk management, biocompatibility, additive manufacturing, cybersecurity and traceability.Using concrete examples (implants, surgical instruments, medical software, cleanrooms, scanners), it traces the essential stages of compliance: design, validation, testing, quality control, document management and certification.The book also highlights the contribution of artificial intelligence to regulatory monitoring, quality assurance and cybersecurity.Through his publications, the author offers concrete support to students, researchers and industrialists, and inspires a new generation to perceive compliance not as a constraint, but as a genuine lever for innovation, safety and global competitiveness.