510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com/u-s-medical-device-510k-premarket-notification.html
510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com/u-s-medical-device-510k-premarket-notification.html
0 Комментарии
0 Поделились
32 Просмотры
English
Arabic
French
Spanish
Portuguese
Deutsch
Turkish
Dutch
Italiano
Romaian
Portuguese (Brazil)
Greek