REQUEST FOR PROPOSAL – IVDR TECHNICAL DOCUMENTATION

Organization should appoint a IVDR experts to for developing and collecting necessary information from various departments. Please fill the below form and submit online.

1. MANUFACTURER INFORMATION

Legal Manufacturer / OEM / OBL Name *:
Street *:
City / Pincode *:
Country *:
Website Address :

2. ADMINISTRATIVE INFORMATION

Notified Body Interested?

Scope of Manufacturer :
Scope of I3CGLOBAL :
Documentation experience and Device Knowledge of the person coordinate with Consultants :

3. MEDICAL DEVICE DESCRIPTION

EU Regulation :
Type of IVD:
Name of the In Vitro Diagnostic Device :

Intended use of the IVD [ ? ]:


Brand Name / Trade Name :
Number of Models [ ? ]:
Class of IVD Device as per IVDR :
Device functions by :
Device Packaging :

Device Tested as per :


4. SUBMITTER INFORMATION

Contact Person * :

Job Title * :

Contact Number *:

Contact Email *:

Date :