Validation for medical device and diagnostic manufacturers. (1997)

• Record Type: Book
• Further Information: Note: Carol V. DeSain, Charmaine V. Sutton.
• Other Names: DeSain, Carol; Sutton, Charmaine Vercimak
• Contents: Introduction to Quality Systems; Validation Overview; Product Development & Validation; Validation Study Plans, Protocols, Reports; Process Development & Validation; Test Method Development & Validation; Qualification of Equipment & Equipment Systems; Qualification of Software-Driven, Automated Equipment & Equipment Systems; Facility Qualification Studies; Validation Studies at Suppliers & Contractors; Change Management for Validated Products, Processes, & Methods; Revalidation & Requalification Studies; Supporting Appendices
• Edition: 2nd ed
• Publisher Details: Place of publication not identified : CRC Press
• Publication Date: 1997
• Extent: 1 online resource (336 pages)
• Subjects: 681/.761; Medical instruments and apparatus -- Quality control; Diagnosis, Noninvasive -- Equipment and supplies -- Quality control; Equipment and Supplies -- standards; Quality Control; Equipment Design; Materials Testing; Software Validation; Médecine -- Appareils et instruments -- Qualité -- Contrôle; Diagnostics -- Méthodes non effractives -- Appareils et matériel -- Qualité -- Contrôle; Medical instruments and apparatus -- Quality control
• Languages: English
• ISBNs: 9781439810460
• Related ISBNs: 143981046X
• 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.