Clinical Evaluation Procedure Bundle
The Clinical Evaluation Procedure Bundle includes Standard Operating Procedures and Forms relating to Clinical Evaluations, Post Market Clinical Follow-Up, Post Market Surveillance and Clinical Investigations.
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Clinical Evaluation Procedure Bundle
The Clinical Evaluation Procedure Bundle is a great value product that includes Standard Operating Procedures and documents relating to Clinical Evaluations, Post Market Clinical Follow-Up, Post Market Surveillance and CE Marking.
Clinical Evaluation Procedure Bundle Contents
The Clinical Evaluation Procedure Bundle includes the following procedures:
1) Clinical Evaluation Procedure
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).
2) Post Market Clinical Follow-Up (PMCF) Plan
Post Market Clinical Follow-up (PMCF) Plan. User friendly, detailed guidance, MDR 2017/745 format. The purpose of the PMCF Plan is to guide users in complying with the requirements of the MDR with respect to the compilation of the PMCF plan.
3) Post Market Clinical Follow-Up (PMCF) Evaluation Report
The PMCF Evaluation Report document guides manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report.
4) Post Market Surveillance Procedure
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plan and Report (Includes Sample Plan); Post Market Clinical Follow-Up (PMCF) requirements; and Periodic Safety Update Reports (PSUR) content when applicable.
5) Clinical Investigation Procedure
The Clinical Investigation procedure includes detailed information on all aspects of clinical investigations. The product includes a CIP protocol and report document, Investigators' brochure (IB) document, investigation site initiation and monitoring forms, informed consent document and guidance on CRF construction.
