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

CONTACT PERSON

GMP/ISO implementation on-site is required for every institution that develops, manufactures, and markets a device in Europe, the United Kingdom, or the United States.

GMP / ISO implementation necessitates full team engagement from all process owners included in the organization structure. In short, GMP/ISO is not a one-man show; it is the result of a collaborative effort to integrate a team into the business.

We, the I3CGlobal team, are considered implementation guides and consultants, and our activities are restricted to providing direction, education, and reviewing documents and reports required for proper implementation.

QMS / GMP Standard

Integration of Standard(s)

Scope Exclusion / Non Applicability

Critical Outsourcing

Appointment of Management Representative

Organization chart and defining of responsibilities of members

Coordinate with Consultants and adhere to schedules.

Attend the prescheduled meeting(s) /process owner interaction

Device Design / Formulation and Development

Verification & Validation

Pre-clinical and clinical studies

Biological and performance studies

Shelf life / Lifetime tests

Usability studies

Post Market Feedback including clinical

Develop SOP/WI/Protocols for the smooth process of day-to-day activities.

1. Review of Organization structure

2. Define ISO/GMP scope

3. Quality Manual, Mandatory procedures drafting

4. Guidance and Process owner Interaction

5. Review of Process owner submitted documents and records

6. Internal Auditor Training for 2-3 employees in the organization

7. ISO 14971 Risk Analysis support

8. Internal Audit Support

9. Onsite support during third-party audits

10. Closing of NC observed by third parties

11. IEC/ISO 62304/82304 support

Phase 1: Estimated offsite document drafting is

Phase 2: Estimated man-days for process owner interaction is

Phase 3: Estimated man-days for Implementation support is

Phase 4: Estimated man-days for training is

Phase 5: Estimated man-days for Internal audit is

Phase 6: Estimated man-days for ISO 62304 Guidance is

Phase 7: Onsite /Offsite Certification audit day support 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 typically takes 3 months for smaller organizations with fewer than 25 workers, and 6 months for those with more than 25 employees. Complex manufacturing procedures, such as sterilization and software integration, might significantly add time to the implementation process.

There will be no certification audit for 21 CFR 820. The timeline for certification in ISO 13485 is also determined by the availability of CB auditors (NB auditors in the case of a combined audit) to audit and certify your organization. Typically, it takes 2 months to organize an on-site assessment and complete 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' performance during the certifying Body assessment.
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 / GMP 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 1500 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