Request For Quote (RFQ) - MDR Technical Documentation
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General and Manufacturer Information
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Scope of Work to be Undertaken by E & E Medicals
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Medical Device Description
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Contact Information
Company Name
Full Name
Telephone
General Information
Name of the Company
Contact Person
Job Title
Contact Number
Contact Email
Website Address
Manufacturer Information
Do you have valid ISO 13485 certificate?
Are you manufacturing a complete device?
Are you manufacturing a device which is a component for other medical device?
Are you manufacturing and selling the medical device in your company name?
Are you packing the manufactured device and selling in your company name?
Are you doing only assembly and packing of the device?
Is the device manufactured using 100% outsourced Components?
Administrative Information
Notified Body Interested?
If others, mention the name
What is his/her background?
Product Knowledge
Scope of Work
General Guidance
Technical File / Design Dossier preparation
Label Review
Closing of Reviewer/Audit Comments
Administrative Information
Name of the Medical device
Intended use of the device [how the medical devices serves the purpose of the device]
Class of Medical Device as per MDD
Is it an invitro diagnostic reagent?
Is it a standalone medical software?
Is the Medical Device used for measuring any Human body attributes?
Is the Device used externally?
Duration of contact with human body
Does the medical device penetrates inside the body
Totally introduced into the body through surgical procedure
Partially introduced into the body through surgical procedure
Is it a reusable medical device?
Are the medical device functions on electricity or any source of energy?
Does the medical device functions in combination with other medical device?
Is the medical device used for Diagnostic purpose?
Is the device used in central circulatory system?
Is the device used in central nervous system?
Is the medical device is made up of animal origin raw materials?
Does the medical device contains any drug?
Medical Device packed in
Medical Device tested as per
Attach the photograph of the product
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Upload product brochure/ manual / Specification / IFU
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