IVDR CE Marking Proposal

1. PREPARED FOR

APPLICANT

ORIGINAL EQUIPMENT MANUFACTURER
OWN BRAND LABELER

Manufacturer Name and Full Address
(To be printed in the CE Certificate)

CONTACT PERSON

APPLICANT
REPRESENTATIVE / CONSULTANT

2. PREPARED BY

Alsstr. 97, 41063 Mönchengladbach, Germany
1st Floor,221,BSK 3 stage,Bengaluru-85, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
336 Sutro Forest NW, Concord, NC 28027, USA
R2202, 609 Truong Dinh, Hoang Mai, Hanoi, VN

NAME

CONTACT NUMBER

DATE

PROPOSAL NUMBER

I3C-IVD--REV:

PROPOSAL VALIDITY

3. EXECUTIVE SUMMARY
This business proposal was submitted with complete confidence in the device, IVDR regulation, and Notified Body requirements. Our scope covers guidance, team consultation, technical documentation, performance evaluation (Limited), Clinical Performance, risk analysis, biological evaluation, labeling, and Notified Body review comment responses. Even if client staff are not directly involved in the technical documentation, it is essential that they communicate with us and provide accurate information, documentation, and records about the facility and product. The client team can keep track of the work at any stage throughout Technical Document preparation and NB review since all customer-provided documents and records will be transmitted in real-time into the cloud. We guarantee that all supplied information will be kept confidential. We have obtained ISO 27701:2016 certification for data security.

3. EXECUTIVE SUMMARY

This business proposal was submitted with complete confidence in the device, IVDR regulation, and Notified Body requirements. Our scope covers guidance, team consultation, technical documentation, performance evaluation (Limited), Clinical Performance, risk analysis, biological evaluation, labeling, and Notified Body review comment responses.

Even if client staff are not directly involved in the technical documentation, it is essential that they communicate with us and provide accurate information, documentation, and records about the facility and product.

The client team can keep track of the work at any stage throughout Technical Document preparation and NB review since all customer-provided documents and records will be transmitted in real-time into the cloud. We guarantee that all supplied information will be kept confidential. We have obtained ISO 27701:2016 certification for data security.

4. DEVICE INFORMATION
1. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
2. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
3. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
4. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
5. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
6. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
7. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
8. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
9. Device Name
Device Class & GMDN Code

Models & Variants
Pricing
10. Device Name
Device Class & GMDN Code

Models & Variants
Pricing

5. PROJECT FEE AND PAYMENT TERMS

IVDR Technical Documentation Fee for the above listed device(s)

(In Words)

With NB Coordination: 40:30:20:10

40% advance, 30% before NB submission, 20% initial NB response, 10% receipt of draft certificate

Without (Phase 10) NB Coordination: 40:30:30

40% advance, 30% after RMF and PER, 30% before technical file handover

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

6. STATEMENT OF WORK

PHASE	ACTIVITY	SCOPE OF I3CGLOBAL	SCOPE OF MANUFACTURER
PHASE 1	Legal Verification	Review and approval	Confirmation of scope
		Review and approval	Confirmation of production site address Law of Land Certificate Company Registration Certificate Incorporation Certificate.
		Review and approval	Confirmation of critical outsourcing locations
		Review and approval	Quality Management Certificate
	Device Verification	Review and approval	Device Models confirmation
		Guidance, Review and Approval	Generic name
		Guidance, Review and Approval	GMDN Code
		Review and approval	Trade Name / Brand Name
		Guidance, Review & Approval	What is to be detected and/or measured
		Guidance, Review & Approval	In-vitro medical device function
		Guidance, Review & Approval	Specific disorder, condition, or risk factor
		Guidance, Review & Approval	Process - automatic or not
		Guidance, Review & Approval	Qualitative, semi-quantitative or quantitative
		Guidance, Review & Approval	Type of specimen(s)
		Guidance, Review & Approval	Testing population
		Guidance, Review & Approval	Intended users
		Guidance, Review & Approval	Companion diagnostics
		Guidance, Review & Approval	Target population
		Guidance, Review & Approval	Associated medicinal product(s)
		Guidance, Review & Approval	Principle of operation
		Guidance, Review & Approval	In vitro diagnostic medical device rationale
		Guidance, Review & Approval	Device classification and justification
		Guidance, Review & Approval	Key components description
		Guidance, Review & Approval	Description of the specimen collection
PHASE 2	Confirmation of IVDR requirements and compliance issues	Identification of regulations
		Harmonized Standards
		Non-Harmonized standards
		Device specific standards
		Other applicable regulations if any
		Declaration of Conformity
		Documentation of additional declarations
PHASE 3	Design Controls (Active, Non-Active Devices) In line with ISO 13485	Design and development procedure.
		Review and Feedback	Development Plan
		Review and Feedback	Design & development inputs
		Review and Feedback	Design & development outputs
		Review and Feedback	Design Verification
		Review and Feedback	Design Validation
		Review and Feedback	Design Approvals
		Review and Feedback	Formulation / Drawings/ Specifications
		Review and Feedback	Bill of Material
		Review and Feedback	Design & development Review
	Design Controls (Software) In line with ISO 62304	Review and Feedback	Development Plan
		Review and Feedback	Requirements Analysis
		Review and Feedback	Architectural Design
		Review and Feedback	Detailed Design
		Review and Feedback	Unit Implementation
		Review and Feedback	Unit Verification
		Review and Feedback	Integration & Integration Testing
		Review and Feedback	System Testing
		Review and Feedback	Software Configuration Management
		Review and Feedback	Software Risk Management Process
		Review and Feedback	The code and code reviews
		Review and Feedback	Software validation and release.
PHASE 4	Risk Analysis & Usability	Development of Procedures and Templates	Conduct of risk Analysis Team support and suggestions
		Guidance
		Risk Mitigation
		Risk Benefit analysis
		Risk Management File documentation	Review and approval
		Usability engineering procedure and template	Team support and suggestions
		Review and approval	Usability engineering report
PHASE 5	Product verification and validation	Analytical performance characteristics	Appoint 3rd party agencies if required) approval
		Guidance, Review & Approval	Accuracy of measurement
		Guidance, Review & Approval	Analytical sensitivity
		Guidance, Review & Approval	Analytical specificity
		Guidance, Review & Approval	Metrological traceability of calibrator and control material values
		Guidance, Review & Approval	Measuring range of the assay
		Scientific Validity Report conclusion	Data generation and approval
		The analytical performance report	Data generation and approval
PHASE 6	Production controls	Guidance, review, and approval	Process Flow Chart
		Guidance	Critical Process identification
		Review and approval	Critical Process validation protocol and reports
		Review and approval	Sterilization Process Validation Protocol
		Review and approval	Sterilization Process Validation Report
		Guidance	Environmental Controls
		Review and approval	Cleanroom Validation protocol and Records
		Review and approval	Bioburden protocol and Records
PHASE 7	Device Labelling	Guidance, review, and approval	Primary / Secondary Labels including embossing’s submit as per guidance
	Information For Use / User manual	Guidance, review, and approval	Develop and submit IFU / User manual as per guidance
	Device Storage	Review, and approval	Confirmation of storage time and condition
	Lifetime / Shelf-Life	Guidance, review, and approval	Lifetime / Shelf-Life Protocol and Reports
	Packaging Controls (Active, Non-Active Devices)	Guidance, review, and approval	Method of Packing
			Packing Validation and Reports
			Transport Validation and Reports
PHASE 8	Quality Control	Review and approval	Specification of Finished Device
		Review and approval	Specification of Critical Raw Materials / Components
		Review and approval	Quality Plan / Control Plan
		Guidance, review, and approval	Certificate of Analysis (COA)
		Guidance, review, and approval	Batch Release
		Review and approval	Performance Testing
		Review and approval	Electrical Safety Testing
PHASE 9	Clinical performance and clinical evidence	Clinical Performance Study Procedure
		Clinical Performance Study plan
		Clinical Performance Study Plan Report	Organize the activities based on guidance
	Post Market Surveillance and Vigilance Reporting	Develops or modifies the PMS procedure, if required Analysis based of collected PMS data based on the reactive and proactive sources selected by the manufacturer. Support PMS planning PMS period confirmation Supports in selecting the sources from our PMS Plan provided by us. Guidance on Vigilance and CAPA if required. Decision on whether PMCF study needs to be conducted based on the feedback and risk classification Preparation of PMS report if Class I or PSUR if class IIa and above Vigilance Control Procedure as per MEDDEV 2.12-1 rev 8	Extent necessary support by following PMS plan scheduled for the period. Collect PMS data based on the PMS sources chosen Organize Customer Feedback Organize Sales History and Sales volume data Organize User Feedback in the drafted and provided. Follow Vigilance and CAPAs if any required. Review and approve PMS plan, other evidence and PMSR/PSUR
	Post Market Performance Follow-up	Prepares procedure for PMPF, if required. Analysis & and derive conclusion.	Follow PMPF study based on Consultants Inputs Review and approve PMPF plan and PMPF Evaluation Report
PHASE 10	Notified Body Submission, Review and Site Audit and Issue of Certificate	Support identification of Notified Body
		Application
		Technical Documentation Submission
		Answering to Notified Body Review comments	Team support and suggestions
		Review draft Certificate	Review draft Certificate
			Accept the electronic and hard copies of the CE Certificate

7. PROJECT TIMELINE
According to our observations of other manufacturers throughout the world, technical documentation typically takes three to four months. Implementation of EN ISO 13485:2016, internal and external testing, validations, and gathering clinical data, among other things, may all be completed in the same amount of time. The typical Notified Body technical documentation review, onsite audit, and certificate issuance procedure for Class B and Class C devices takes nine months to a year, and longer for Class D devices.

7. PROJECT TIMELINE

According to our observations of other manufacturers throughout the world, technical documentation typically takes three to four months. Implementation of EN ISO 13485:2016, internal and external testing, validations, and gathering clinical data, among other things, may all be completed in the same amount of time.

The typical Notified Body technical documentation review, onsite audit, and certificate issuance procedure for Class B and Class C devices takes nine months to a year, and longer for Class D devices.

8. GENERAL TERMS OF BUSINESS
8.1 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. 8.2 PROPOSAL 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. 8.3 GUARANTEE ON PROJECT OUTCOME We are unable to promise CE Certification. To successfully complete the project, we will continually rely on our technical proficiency and experience in earlier project completion. The manufacturers' onsite QMS implementation, the quality of the materials, finished product, and performance evaluation are aspects that affect CE certification. 8.4 NOTIFIED BODY REVIEW FEE The Notified Body conducts technical documentation reviews a maximum of two to three times. Additional reviews will incur fees in accordance with the signed agreement's terms with the manufacturer and notified body. We cannot guarantee that the technical file will be approved after two reviews. As consultants, our goal is to complete each project successfully with the fewest feasible expenditures and time delays. 8.5 NON-AVAILABILITY OF TECHNICAL INFORMATION WITH MANUFACTURER The manufacturer (OEL/OBL/PLM) must organize documents/records/device technical information at our consultants' request. All submitted items must always be assessed by our team, who will formally notify you if they are unacceptable. The manufacturer must take the necessary steps to fix it. Any delays incurred are not our fault. 8.6 SURPRISE EXPENSES AFTER PROJECT START Based on the device characteristics, raw materials utilized, inadequate data, sales feedback, clinical feedback, and device-specific international and harmonized standards, extra costs may arise after project start-up based on our thorough investigation. 8.7 DOCUMENT SECURITY AND PROJECT CONTACTS The technical file is being handled, prepared, reviewed, and protected at the central depository located in Bangalore, India. The project-related first-line point of contact is the team lead. The guidance and technical documentation will be taken up by technical consultants. If you feel there is an unresolved issue or a matter that requires additional attention, you should contact the project head who has signed clause 10 of this proposal. 8.8 REFUND If a discrepancy in clause 4 is detected after the project begins, payments will not be refunded. 8.9 CONSULTANT(S) VISIT TO MANUFACTURER LOCATION. Most of the time, a consultant doesn't need to go to the manufacturer's facility. If any unresolved concerns, we may send a member to your location to address them. Based on the availability our experts travel from Chicago, Bangalore, Düsseldorf, and London. The manufacturer is required to make travel and accommodation arrangements. 8.10 PROJECT DELAY PENALTY We are committed to finishing tasks on schedule. The CE Certification procedure is divided into three steps. They are (1) Technical Documentation (2) Technical Documentation Review by Notified Body (3) Onsite Audit. The technical documentation must be sent to the notified body within five months, and this is the joint duty of I3CGLOBAL and the manufacturer. Therefore, whoever is to blame for a delay that lasts more than six months must pay $50 a day in compensation

9. 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

10. 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 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