Theisz, Val,

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.

K3611.M45 / T44 2016

344.041 / T377