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/NBOp Letter))

CONTACT PERSON

APPLICANT
REPRESENTATIVE / CONSULTANT

2. PREPARED BY

25, Jalan Setia Utama U13/37D, Malaysia
1st Floor,221,BSK 3 stage,Bengaluru-85, India
58, Peregrine Road, Essex, England, IG6 3SZ, UK
31914, J N Pease Pl, Charlotte, NC, 28262, USA
12-21, JNM GLOBAl, Seoul, South Korea

NAME

CONTACT NUMBER

DATE

PROPOSAL NUMBER

I3C-CEC--REV:

PROPOSAL VALIDITY

3. EXECUTIVE SUMMARY
This business proposal was submitted with complete confidence in the device, MDR regulation, and Notified Body requirements. Our scope covers guidance, team consultation, technical documentation, clinical evaluation, 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, MDR regulation, and Notified Body requirements. Our scope covers guidance, team consultation, technical documentation, clinical evaluation, 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

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

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

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

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

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

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

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

Models & Varients
Pricing
9. Device Name
Device Class & GMDN

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

Models & Variants
Pricing
11. Device Name
Device Class & GMDN

Models & Variants
Pricing
12. Device Name
Device Class & GMDN

Models & Variants
Pricing

5. PROJECT FEE AND PAYMENT TERMS

MDR 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% draft CE certificate or NBOp

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

40% advance, 30% after RMF and Literature Search, 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
		Review and approval	Device Variants confirmation (Stock Keeping unit) SKU
		Medical Device Rational
		Guidance, Review and Approval	Device Description
		Review and approval	Identifying key functional component Device Components
		Review and approval	Device Accessories
		Guidance, Review and Approval	Hardware / firmware / software
		Guidance, Review and Approval	Intended use
		Guidance, Review and Approval	Specification
		Risk Classification
		Review and approval	Software Level of Concern
		Review and approval	Indication
		Review and approval	Mechanism of Action
		Review and approval	Connections to the device
PHASE 2	Confirmation of MDR 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	Pre- Clinical	Biological Evaluation procedure and templates
		Identification of biocompatibility compliance requirements
		Identification of electrical safety compliance requirements
		Review and approval	Biocompatibility Plan
		Review and approval	Biocompatibility Test Reports
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 Evaluation	Development of Quality System Procedure, if not available with the manufacturer. I3C may modify or suggest modifications to the manufacturer’s existing QSP.	Extend necessary support with document numbering based on MDQMS and control of documents
		Guidance and drafting of templates	Assign clinical evaluator(s) as per the guidance and arrange the CV and DOI
		Develop detailed Clinical Evaluation Plan Develop the CEP template and fill it based on the evidence provided by the manufacturer such as IFU or User guide, RMF or previous CER. Develop Literature search plan template and add information of literature search strategies. Develop Appraisal plan template and add information - the criteria for appraisal of all the pertinent data.	Clarify doubts, when necessary. Assign other responsible personnel involved in clinical evaluation and inform I3C Review and approve CEP, Literature search plan and Appraisal plan
		Develop Identification of Pertinent Data template Guides manufacturer on pre-clinical and non-clinical studies. Identifies data that can be retrieved from manufacturer and adds data based on that to the template	Extend necessary support for consultants with pre-clinical data in a systematic way. Provide information of any clinical studies such as Clinical investigations as ISO 14155 or Post-market studies on the device
		Develops relevant Literature search and review report template Performs a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, GSPR [MDR] and SOTA/SOA, and prepares the literature search report for meeting the requirement of safety and performance of the device Prepares literature search review report based on the review questions added in Literature search plan.
		Develops Demonstration of Equivalence template based on MDCG guidance Performs demonstration of equivalence Informs about similar device details obtained from pieces of literature (if any)	Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency) As applicable, a contract must be signed between your company and the manufacturer of the equivalent device if your product is Class III or implantable or must have access to equivalent device data on an on-going basis, if any other classes (if applicable)
		Develops appraisal of pertinent data template Appraises the clinical data collected from the manufacturer as well as that from the literature search based on the criteria set in the Appraisal plan
		Develops analysis of clinical data template Performs qualitative analysis of the clinical data obtained from the literature as well as data retrieved from the manufacturer based on the essential requirements and corresponding GSPRs.
		Develops CER template Adds information on the CER template based on the summary of inputs from the clinical data provided by the manufacturer and/or the literature or from the Clinical investigation report from stage 1 to stage 3 meeting the GSPRs
	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 Clinical Follow-up	Prepares procedure for PMCF, if required. Prepares PMCF Plan & Evaluation Report templates based on the MDCG guidance Support in selection of device for PMCF Review the data entered in the PMCF plan to meet the chosen PMCF objective Guides manufacturer to choose the suitable method as per the characteristics and type of medical devices. Develops a well-defined PMCF study template and PMCF evaluation report template Verifies the findings and the results based on the PMCF activity chosen by the manufacturer. Analysis & Conclusion based on the study (by the evaluator) in the PMCF evaluation report.	Extend necessary support by following the PMCF plan Follow PMCF period selected in line with the PMS Identify List of Study Centres Method of PMCF study based on Consultants Inputs Clinical Investigation (If applicable) to be outsourced to third party agency Review and approve PMCF plan, other evidence and PMCF Evaluation Report
PHASE 10	Notified Body Submission, Review, Onsite Audit and Issue of Certificate or NBOp Letter	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 CE Certificate (Soft/Hard) or NBOp Letter

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 CE certificate / NBOp letter issuance procedure for Class Is, Ir, Im, and Class IIa devices takes nine months to a year, and longer for Class IIb and Class III devices. According to Article 54 of the new law, NBs must submit Clinical Evaluations of certain high-risk devices for review by an expert panel as part of a new "consultation procedure." For specific high-risk technologies, Article 55 develops a new "system for evaluating conformity evaluations." It is anticipated that the new obligations placed on NBs would affect the timing of approvals.

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 CE certificate / NBOp letter issuance procedure for Class Is, Ir, Im, and Class IIa devices takes nine months to a year, and longer for Class IIb and Class III devices. According to Article 54 of the new law, NBs must submit Clinical Evaluations of certain high-risk devices for review by an expert panel as part of a new "consultation procedure." For specific high-risk technologies, Article 55 develops a new "system for evaluating conformity evaluations." It is anticipated that the new obligations placed on NBs would affect the timing of approvals.

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. 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 / NBOp letter. 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 used, the finished product, and post-market feedback are other 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, Charlotte, Bangalore, Düsseldorf, and London. The manufacturer is required to make travel and accommodation arrangements. 8.10 PROJECT DELAY PENALTY We intend to finish the technical documentation in 3-5 months. We have put in place a strong mechanism for tracking progress on a weekly basis, which we will communicate to all stakeholders every Friday. I3CGLOBAL is committed and promises to pay $50 per day for any delay over 150 days if the technical documentation is not sent to the NB/Manufacturer. For a successful CE Certification, the technical team from the client/manufacturer must coordinate and cooperate with actual facts and accurate information regarding devices via email in response to each query/question presented by consultant team members. As a result, we request that the manufacturer team adhere to the same compensation payment of $50 per day for any delay caused by them beyond 150 days.

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