Consultation and Training in Medical Devices

Expert in ISO 13485, GDPMD, MDA Regulatory Requirements, CE marking, FDA related and Medical Device Related Requirements

Thursday

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