Medical device regulatory practices : an international perspective / Val Theisz.
By: Theisz, Val [author.]
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Material type: 
BookPublisher: Boca Raton : CRC Press, [2016]Copyright date: ©2016Description: 1 online resource.Content type: text Media type: computer Carrier type: online resourceISBN: 9780429091469.Subject(s): Medical instruments and apparatus -- Safety regulationsAdditional physical formats: Print version: : No titleDDC classification: 344.041 Online resources: Click here to view.
Contents:
1. Overview of the international regulatory framework for medical devices -- 2. Safety and effectiveness -- 3. Technical documentation -- 4. Pre-market phase -- 5. Regulatory submissions, approvals and registrations -- 6. Post-market phase.
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1. Overview of the international regulatory framework for medical devices -- 2. Safety and effectiveness -- 3. Technical documentation -- 4. Pre-market phase -- 5. Regulatory submissions, approvals and registrations -- 6. Post-market phase.
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