Request For Quote (RFQ) - CER Technical Documentation

Organization should appoint a MDR (Medical Device Regulation) Expert to interact with consultant for developing and collecting necessary information from various departments. Please fill the below form and submit online.

1. MANUFACTURER INFORMATION

1.1 Manufacturer / Legal Manufacturer Name *:
1.2 Website Address :

2. ADMINISTRATIVE INFORMATION

2.1 Notified Body Interested?

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

3. MEDICAL DEVICE DESCRIPTION

3.1 EU Regulation :
3.2 Type of Device:
3.3 Name of the Medical device :

3.4 Intended use of the device [ ? ]:



3.5 Device Brand Name / Trade Name :

3.6 Number of Models [ ? ]:

3.7 Class of Device as per MDR :
3.8 Class of Medical Device as per IVDR :
3.9 Device Body Contact :
3.10 Device Invasive action by :
3.11 Medical device functions by :
3.12 Is the device used in :
3.13 Medical Device packed :

3.14 Medical Device Tested as per :


4. SUBMITTER INFORMATION

4.1 Contact Person * :

4.2 Job Title * :

4.3 Contact Number *:

4.4 Contact Email *:

4.5 Date :