ISO 13485:2016 : a complete guide to quality management in the medical device industry

• Main Author: Abuhav, Itay, (Author)
• Format: eBook
• Language: English
• Published: Boca Raton : CRC Press, Taylor & Francis, [2018]
• Edition: Second edition.
• Subjects: Medical instruments and apparatus industry > Standards.; Quality control.; Quality control > Handbooks, manuals, etc.; elektronické knihy; electronic books
• ISBN: 9781351000772; 1351000772; 9781351000796; 1351000799; 9781351000789; 1351000780; 9781523118106; 1523118105; 9781138039179; 1138039179
• Physical Description: 1 online resource (xiii, 877 pages)

"This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality managemen...