Medical devices : regulations, standards and practices /: regulations, standards and practices. (2015)

• Record Type: Book
• Further Information: Note: Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo.
• Authors: Ramakrishna, Seeram; Tian, Lingling; Wang, Charlene; Liao, Susan; Teo, Wee Eong
• Contents: 1 Introduction Part One 2 General regulations of medical devices 3 Quality management systems for medical device manufacture 4 The process of gaining approval for new medical devices Part Two 5 Risk assessment and management for a new medical device 6 Safety testing of a new medical device 7 Clinical testing of a new medical device 8 Product development overview Part Three 9 Case study: Successful development and approval of a new medical device 10 Global harmonization of medical devices
• Publisher Details: Oxford : Woodhead Publishing
• Publication Date: 2015
• Extent: 1 online resource
• Subjects: 610.28; Medical instruments and apparatus; Biomedical engineering
• Languages: English
• ISBNs: 9780081002919
• Related ISBNs: 9780081002896
• Notes: Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.