1. PREPARED FOR

Sponsor / Applicant Name and Address
(To be printed on the test reports)

EU MDR/IVDR Compliance
FDA 510K Compliance
CE + 510k Compliance
Design Verification

CONTACT PERSON

MANUFACTURER
APPLICANT REPRESENTATIVE / CONSULTANT



2. PREPARED BY
Alsstr. 97, 41063 Mönchengladbach, Germany
S-8, JJ Park 2, 4th Cross, Bangalore-560029, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
75 Executive Drive, 303, Aurora, Illinois-60504, USA
R2202 CT2B, 609 Truong Dinh, Hoang Mai, Hanoi, VN
NAME
CONTACT NUMBER
EMAIL
DATE
PROPOSAL NUMBER I3C-TEST--REV:
PROPOSAL VALIDITY
 
3. EXECUTIVE SUMMARY

The business proposal was submitted to the manufacturer with complete confidence that it would be approved by the appropriate authorities in the EU CE Marking, UKCA Marking, and US FDA 510k.

The technical inputs provided by the manufacturer to I3CGLOBAL for subsequent submission to laboratories must be legitimate and genuine. All samples submitted must be made in the manufacturer's facility, QC tested, and approved for market release by QA.
4. DEVICE INFORMATION

1. Device Name

    Sterlity

    Body Contact Duration

    Risk Class (EU/FDA)

2. Device Name

    Sterlity

    Body Contact Duration

    Risk Class (EU/FDA)

3. Device Name

    Sterlity

    Body Contact Duration

    Risk Class (EU/FDA)

4. Device Name

    Sterlity

    Body Contact Duration

    Risk Class (EU/FDA)
5. TEST REQUIREMENTS AND FEES
Test Selection
 Test Name Qty Total Fees Timeline
Cytotoxicity
Sensitization
Intra-cutaneous / Irritation
Material medicated Pyrogenicity
Acute systemic toxicity
Subacute toxicity
Subchronic toxicity
Implantation Effects
Hemocompatibility
Genotoxicity - Bacterial reverse mutation
Genotoxicity - Chromosomal aberration test
Hemolysis test (Direct & Indirect contact method)
Hemocompatibility: Partial thromboplastin time – PTT
Hemocompatibility: (Platelets and Leucocytes)
Hemocompatibility: Platelet Activation Test
Carcinogenicity
Reproductive/developmental toxicity
Biodegradation
Ethylene oxide sterilization residuals
Degradation from polymeric
Degradation from ceramics
Degradation of metals and alloys
Limits for leachable substances
Chemical characterization

Total Cost:



Payments in two installments - 50% before testing and 50% after approval of protocol (before testing).

Payments must be made on tax invoices issued in accordance with the applicable government laws in effect at the time of invoicing. We recommend paying using PayPal with an extra 4.7 percent convenience charge for quick processing.
6. GENERAL TERMS OF BUSINESS

6.1 TEST SAMPLE

  • Quantity of items for testing will be intimated after receipt of payment and below (sec 6.2) information
  • Test samples will not be returned.
  • It is always preferable to obtain test samples in their final packaging (device ready for sale / marked release).
6.2 SAMPLE INFORMATION
  • Batch Number
  • Manufacturing Date and Expiry Date
  • Sterility Nature
  • Storage temperature
  • Surface area of the device.
  • Body Condact duration.
  • Type of implementation and implant duration if applicable.
6.3 TEST RESULT
  • We will not refund the payment in case of a test failure.
  • Exact fees and timeline applicable for test repetition
6.4 LABORATORY ACCREDITATION
We will attach an accreditation copy along with the test report
6.5 SELECTION OF STANDARDS
We perform testing in accordance with current ISO standards (EU/FDA) and/or customer-supplied standards. The aforementioned clause does not apply to customers who have obtained technical help for biological evaluation, risk analysis or risk mitigation.

 
7. PROPOSAL REVIEW
Name : Soio George
Designation : Project Head
Email : sg@i3cglobal.com
Date :

I read, reviewed, and confirmed that the information is accurate to the best of my knowledge. I appreciate the opportunity to present our proposal to you, and I look forward to working with you.

I accept

 
8. PROPOSAL APPROVAL

Name :
Designation :
Email :
Date :

I acknowledge that I have read and understand the working pattern, scope of both parties, risk involved, and potential variations in test results and timetables, and I now accept them. I3CGLOBAL is now requested to submit an advance payment invoice so that the project can begin as soon as possible.

I accept