Design controls for the medical device industry

• Main Author: Teixeira, Marie B., 1965- (Author)
• Format: eBook
• Language: English
• Published: Boca Raton : Taylor & Francis, [2013]
• Edition: Second edition.
• Subjects: Medical instruments and apparatus > Design and construction.; Medical instruments and apparatus industry.; Quality control.; elektronické knihy; electronic books
• ISBN: 9781466503557; 1466503556; 9781628707120; 1628707127; 9781466503540; 1466503548
• Physical Description: 1 online resource

"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also su...