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(EN) ISO 13485:2016 Implementation [Request For Quote]
Please fill the below form and submit to us.
1. GENERAL INFORMATION
1.1) Name of the Company :
1.2) Contact Person :
Mr
Mrs
Dr
Prof
Ms
1.3) Job Title :
1.4) Contact Number :
1.5) Contact Email :
1.6) Website Address :
2. MANUFACTURER INFORMATION
2.1) Scope of ISO 13485 Implementation
(Scope to be defined in the Quality Manual)
:
2.2) Name the organization responsible for Design :
2.3) Are you undertaking sterilization?
Yes
No
2.4) Are you a
legal manufacturer
?
Yes
No
3. ADMINISTRATIVE INFORMATION
3.1) Shop floor area in Sq. Ft. :
Select
Less Than 1000 Sq. Ft
1000 - 2000 Sq. Ft
2000 - 5000 Sq. Ft
5000 - 10000 Sq. Ft
Above 10000 Sq. Ft
3.2) No. of employees :
3.3) No. of Shift :
Select
1
2
3
3.4) Mode of Business :
Select
OBL /PLM
Joint Venture
Collobration
OEM
Loan Liscense
4. TECHNICAL INFORMATION
4.1) Do we need to support in Development of Quality Manual ?
Yes
No
4.2) Do we need to support in Developing Procedures ?
Yes
No
4.3) Do we need to develop Forms/Format ?
Yes
No
4.4) Do we need to interact with individual process owner ?
Yes
No
4.5) Dedicated person appointed as Management Representative ?
Yes
No
4.6) Planning for CE Marking in future?
Select
Yes, after 3 years
Yes, after 5 years
No
No comments
4.7) Any relevant Information which you feel important to understand more about your organizaton :
4.8) Attach the photograph of the product :
4.9) Upload product brochure/ manual / Specification/ IFU :
4.10) Information provided by :
Mr
Mrs
Dr
Prof
Ms
4.11) Date :
Receive copy of the filled RFQ, Please provide email ID
:
