What is a Clinical Investigation?
Medical device manufacturers must meet the requirements of ISO 14155 when conducting clinical investigations to demonstrate the safety and effectiveness of their products for use purposes.
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1. The clinical investigation evaluation data shall include the following
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- Risk assessment
- Evaluation of justification for a designed clinical investigation
- Clinical investigation plan
- Investigator's Brochure
- Case Study Report
- Monitoring plan
- Reasons for selecting a place for clinical investigation
- Consent
- The method of identified clinical subjects
- Data Review Committee
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2. The clinical investigation shall be carried out in accordance with the clinical investigation plan. Approval in accordance with clinical investigations varies from member countries of the European Union.
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- You must have information about the initial clinical investigation site.
- Periodic monitoring of clinical investigation sites is required.
- Include data on side effects, device defects, etc.
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3. The clinical investigation document shall include the following.
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- Modifications
- Subject identification table
- List of clinical investigation teams and other personnel
- Confidentiality contract for the subject, etc
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