Awọn ẹya

1. Ifihan si Imọye Oríkĕ ati Ijẹrisi Ijẹrisi ni Imọ-ẹrọ Biomedical 2. Atilẹyin Aworan Iṣoogun: Radiology (X-ray, CT, MR) 3. Digital Pathology ati Tissue Image Analysis 4. Ṣiṣẹ Biosignal: ECG ati Awọn ifihan agbara ọkan 5. Ilana Biosignal: EEG ati Awọn ifihan agbara Neurological 6. Awọn sensọ ti o wọ ati Abojuto Ẹkọ-ara Tesiwaju 7. Isẹgun Data Analysis ati Itanna Health Records 8. Apẹrẹ Ẹrọ iṣoogun ati sọfitiwia Ẹrọ (SaMD) 9. Iwadi Ilana ati Imudaniloju: CE/FDA, MDR 10. Iwa, Aṣiri Alaisan ati Isakoso Data (KVKK/HIPAA) 11. Isopọpọ-Opin-si-Ipari, Awọn aala ati Ipaniyan Lodidi

Ẹyọ 9 / 11

Iwadi Ilana ati Imudaniloju: CE/FDA, MDR

Awọn anfani:

Agbara lati ṣe alaye iwadii ati atilẹyin kikọ ti oye atọwọda laarin ilana ti isamisi CE, awọn ipa ọna FDA ati Ilana Ẹrọ Iṣoogun (MDR)
Loye pe awọn abajade ọrọ ilana n gbe eewu ti awọn itọka ti a ṣẹda ati awọn nkan eke ati bii o ṣe le rii daju wọn.
Agbara lati pinnu ibiti AI dopin fun igbelewọn ile-iwosan, ijẹrisi / afọwọsi (V&V) ati dossier imọ-ẹrọ

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