Clinical Evaluation Procedure Bundle
SKU:
CEBNDL
$499.00
$499.00
per item
The Clinical Evaluation Procedure Bundle includes Standard Operating Procedures and Forms relating to Clinical Evaluations, Post Market Clinical Follow-Up, Post Market Surveillance and CE Marking.
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MEDDEV 2.7.1, Rev 4
- MS Word Format
- Instant Download Digital Content
Clinical Evaluation Procedure BundleThe Clinical Evaluation Procedure Bundle is a great value product that includes Standard Operating Procedures and templates relating to Clinical Evaluations, Post Market Clinical Follow-Up, Post Market Surveillance and CE Marking.
Clinical Evaluation Procedure Bundle ContentsThe Clinical Evaluation Procedure Bundle includes the following procedures:
1) Clinical Evaluation ProcedureThe Clinical Evaluation Procedure governs the entire clinical evaluation process from scope definition through Clinical Evaluation Report (CER). The MEDDEV 2.7/1 Rev 4 compliant Clinical Evaluation Procedure also governs Post Market Clinical Follow-up (PMCF).
2) Post Market Clinical Follow-Up (PMCF) PlanPost 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 ReportThe PMCF Evaluation Report template guides manufacturers in complying with the requirements of the MDR with respect to the compilation of the PMCF evaluation report.
4) Post Market Surveillance ProcedureThe 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) CE Marking ProcedureThe CE Marking Procedure provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.
Clinical Evaluation Procedure Bundle ComplianceThe Clinical Evaluation Procedure Bundle is MEDDEV 2.7.1 Rev 4, MDR 2017/745, FDA QSR and ISO 13485:2016 compliant.
For more information about our Clinical Evaluation Procedure Bundle contact us at info@aplyon.com
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Clinical Evaluation Bundle Contents
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