Role of Consultants & Clients
in the development of Clinical Evaluation Report for Medical Device
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DOCUMENTATION |
SCOPE OF WORK (I3CGlobal) |
SCOPE OF WORK (Client) |
STAGE 0 |
0.1 Clinical Evaluation Procedure |
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0.2 SOP for Clinical Evaluation Plan | |||
0.3 Clinical Evaluation Plan | |||
0.4 Draft of Declaration of Interest (DOI) | |||
0.5 CV of the Evaluator |
STAGE 1 |
1.1 SOP for Identification of Pertinent Data |
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1.2 Data Retrieved from the Manufacturer | |||
1.3 SOP for Literature Search and Review | |||
1.4 Literature Search and Review Plan | |||
1.5 Literature Search and Review Report |
STAGE 2 |
2.1 SOP for Demonstration of Equivalence |
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2.2 Demonstration of Equivalent Devices | |||
2.3 SOP for Appraisal of Clinical Data | |||
2.4 Clinical Data Appraisal Plan | |||
2.5 Appraisal of Pertinent Data | |||
STAGE 3 |
3.1 SOP for Analysis of the Clinical Data |
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3.2 Analysis of the Clinical Data |
STAGE 4 |
4.1 SOP for Development of CER |
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4.2 Clinical Evaluation Report with below supporting evidences | |||
4.2(a) Risk Analysis procedure + Risk Management File | |||
4.2(b) Post Market Surveillance (PMS) procedure + Records Templets + PMS Plan + PMS records (Client must organize as per our guidance) | |||
4.2(c) Post Market Clinical Follow-up (PMCF) procedure + Records Templets + PMCF records (Client must organize as per our guidance) |
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4.2(d) Periodic Safety Update Report (PSUR) | |||
4.2(e) IFU |
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I3C SCOPE (General) |
CLIENT SCOPE (General) |
01 |
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02 |
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