APPLICANT Name & Full Address
(To be printed in the Certificate)

CONTACT PERSON

We submit our business plan with complete confidence in the MDR/IVDR regulatory process, as well as FDA 21 CFR 820 regulations, if applicable. We can entirely customize your QMS / GMP quality system to meet your specific needs and ensure FDA or CB audit success. If all process owners keep procedures and objective evidence up to date and provide them when auditors want them, we can assure audit/inspection success.

QMS / GMP Standard

Integration of Standard(s)

Scope Exclusion / Non Applicability

Scope

Critical Outsourcing

Preclinical and non-clinical tests

Performance tests

Shelf life / Lifetime tests

Validation

Post Market Feedback including clinical

Identification of Process owner(s) for each activity

Appointment of the management representative

Follow the ISO implementation schedule and monitor the effectiveness

1. Initial Document Drafting

2. Process owner Interaction

3. Review of customer submitted documents

4. Implementation Support

5. General awareness training

6. Internal Auditor Training

7. Internal Audit Support

8. Certification Body audit day support

9. Certification Body NC closing support

10. Risk Analysis support

11. ISO 62304 Guidance and identification of mandatory requirements

12. CFR 820 System Integration

Estimated offsite document drafting is man-days and fee is

Estimated man-days for process owner interaction is and fee is

Estimated man-days for Implementation support is and fee is

Estimated man-days for training is and fee is

Estimated man-days for Internal audit is and fee is

Estimated man-days for ISO 62304 Guidance is and fee is

Onsite /Offsite Certification audit day support is man-days and fee is

Total Project Fee:

(In words):

Expected Delivery within 90/120 days.

All payments to I3CGLOBAL must be made using the tax invoices generated according to the schedules above.

Strict Implementation usually takes 3 months for smaller companies with less than 25 employees and those above will take 6 months also. Complex manufacturing processes (example: sterilization) can also prolong the implementation process.

The timeframe for certification is also dependent upon the availability of CB auditors (NB auditors in case of combined audit) to audit and certify your company. Usually 2 months is sufficient to schedule an on-site audit and completed the Certification process.

9.1 NON-DISCLOSURE AGREEMENT.
All Confidential Information statements and information of any kind given by the applicant will be treated with the highest secrecy and confidence. Without the applicant's specific written approval, we will not divulge such Confidential Information to any third party. Directors, officers, employees, and consultants will use the Confidential Information disclosed pursuant to this Agreement solely for the Purpose, and will ensure that such persons are bound by confidentiality obligations that limit the disclosure and use of the Confidential Information as contemplated by this Agreement.
9.2 TRAVEL AND ASSOCIATED EXPENSES .
If a consultant visit is necessary, travel and lodging will be charged separately. Before scheduling the appointment, clients will be informed of the extra charge.
9.3 MODIFICATION.
No modification, termination, or attempted waiver of this agreement, or any component of it, shall be valid unless it is in writing and signed by the party seeking to enforce it.
9.4 NO GUARANTEE.
We can't promise a positive outcome or early certification. The outcome is entirely dependent on the process owners' i.e., the quality of records generated against each procedure and performance during the certifying Body onsite audit.
9.5 NO REFUND.
We will not return any money made after the project has begun. If there are any outstanding payments from the client as a result of the extra manpower provided, we will continue to submit the invoice.
9.6 DELAY PENALTY .
I3CGlobal is concerned about meeting the ISO Implementation and Certification deadline. Once a date has been agreed upon, both parties must reimburse whoever is responsible for the delay. The monthly delay penalty is 500 USD.

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

I acknowledge that I have read and understand the working pattern, scope of both parties, risk involved, and potential variations in project assumptions 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