QNET BV Medical Device/IVD/ Authorized Representative
Request for proposal
Company Name
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Address
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City
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State/Province
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Country
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Phone Number
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Website
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Contact Person
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E-mail
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Confirmation Email
Brief Description and Intended Use of the device
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Is this a Medical Device as defined in the Medical Device Regulations
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Yes
No
Is this an Invitro-Diagnostic as defined in the Directive?
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Yes
No
Under which Risk Class and Rule does your device fall under in the Medical Device regulations of IVD Directive?
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Do you have a Technical File that complies with the requirements of the Medical Device Regulations or the IVD Directive?
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Yes
No
Is this device sterile?
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Yes
No
Does the device use electrical power?
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Yes
No
Does the device contain software?
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Yes
No
Does the device contain any pharmaceutical agents?
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Yes
No
Does the device contain any substance of animal or human origin?
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Yes
No
Is the device intended to be used with other devices?
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Yes
No
Is this device sold on the internet?
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Yes
No
Is your company ISO 13485 certified?
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Yes
No
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