PERMOHONAN CE MARKING DAN FDA 51OK UNTUK ALATAN PERANTI PERUBATAN (MEDICAL DEVICE)

 KHIDMAT KONSULTANSI DAN FASILITASI

1. PERSIJILAN ISO 13485

2. EUROPEAN REPRESENTATIVE - CE MARK

3. PRODUCT NOTIFICATION

4. DECLARATION OF CONFORMITY

5. TECHNICAL FILE DEVELOPMENT

6. PENDAFTARAN FDA ESTABLISHMENT

7. APPLIKASI FDA 510K (PENDAFTARAN MEDICAL DEVICE)

INDUSTRI SASARAN:

GLOVE MANUFACTURER, GLOVE TRADING, GLOVE EXPORTER, SYRINGES MANUFACTURER, SYRINGE EXPORTER