Тёмный

How to do Software as Medical Device Development correctly? 

Easy Medical Device
Подписаться 14 тыс.
Просмотров 6 тыс.
50% 1

Опубликовано:

 

9 сен 2024

Поделиться:

Ссылка:

Скачать:

Готовим ссылку...

Добавить в:

Мой плейлист
Посмотреть позже
Комментарии : 7   
@gabrielrennes
@gabrielrennes 3 года назад
VERY VERY interesting and useful
@christiankaestner6511
@christiankaestner6511 2 года назад
I'm happy you liked the content. Perhaps you also like the content presented in this webinar: ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-FQrjnTuE8K0.html
@yannickmoukamtchokote7670
@yannickmoukamtchokote7670 2 года назад
Great video. One question , is it possible to combine the design transfer and the Software configuration management in one document?
@christiankaestner6511
@christiankaestner6511 2 года назад
You are always free to combine information as you find it meaningful. The challenge you might face is that auditors might look for specific documents, but it shouldn't be a problem if you explain your approach. You might find this video helpful, where I'm talking about documenting compliance with IEC 62304: ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-SHNFJQ_81YE.html&t
@adalid500xd
@adalid500xd 2 года назад
I have a question! Can a MDSW be a device supplying energy?
@adalid500xd
@adalid500xd 2 года назад
Or even, active implantable? Thank you so much!
@EasyMedicalDevice
@EasyMedicalDevice 2 года назад
An active device can include a Software so yes a MDSW can be part os an active device.
Далее
АХХАХАХАХАХАХАХАХ
00:16
Просмотров 125 тыс.
Harvard i-lab | Understanding Medical Device Development
1:26:42
Digitizing your SaMD Testing
35:14
Просмотров 104
Medical Device Software Development Short Course
23:06