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Request For Quote (RFQ) – MDR Technical Documentation

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
  • General Info
  • Scope of Work
  • Device Description

Contact Information

Company Name

Full Name

Email

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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Information provided by

Date

Receive copy of the filled RFQ, Please provide email ID