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Medical Device Clinical Investigation Plan
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$49.00
$49.00
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The Clinical Investigation Plan (CIP) complies with ISO 14155:2020. Robust 28 page user friendly form addresses each required clinical investigation plan element defined in ISO 14155 and MDR 2017/745.
- ISO 14155:2020 Compliant
- MDR 2017/745 Compliant
- MS Word Format
- Instant Download - Digital Product
Clinical Investigation Plan (CIP)The Clinical Investigation Plan (CIP) complies with ISO 14155:2020. Robust 28 page user friendly form addresses each required clinical investigation plan element defined in ISO 14155 and MDR 2017/745.
Clinical Investigation Plan - ComplianceThe Clinical Investigation Plan complies with requirements of MDR 2017/745 and ISO 14155:2020.
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The Clinical Investigation Report complies with the requirements of ISO 14155:2020. The report provides an excellent structure for summarizing the clinical investigation plan, communicating results of the investigation and overall conclusions.
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Clinical Investigation Procedure
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The Clinical Investigation Procedure complies with ISO 14155. The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report template, Investigators' brochure (IB) template, investigation site initiation and monitoring forms, informed consent template and guidance on CRF construction.
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The Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER). The Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).
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Medical Device Quality Management System | MANUFACTURING PLUS
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The Medical Device Quality Management System | MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices seeking ISO 13485 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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