REQUEST FOR PROPOSAL – CLINICAL EVALUATION REPORT DOCUMENTATION

The organization should appoint experts and writers for developing a fully complied clinical evaluation report. The filled form helps us get more details about medical devices and manufacturers. Fill separate forms for each device.

1. MANUFACTURER INFORMATION

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

2. ADMINISTRATIVE INFORMATION

Notified Body Interested?

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

3. MEDICAL DEVICE DESCRIPTION

Name of the Medical device :

Intended use of the device [ ? ]:


Device Brand Name / Trade Name :
Number of Models [ ? ]:
Class of Device as per MDR :
Status of EU 2017/745 Technical Documentation:
Device Body Contact :
Device Invasive action by :
Medical device serve functions by :
Special Features :
Medical Device packed :
Name the accessories ( If Nil write NA) :
Name the Components ( If Nil write NA) :



4. SUBMITTER INFORMATION

Contact Person * :

Job Title * :

Contact Number *:

Contact Email *: