Medical device regulatory practices : an international perspective /
Val Theisz.
- 1 online resource
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.
9780429091469
10.1201/b18817 doi
Medical instruments and apparatus--Safety regulations.