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- Post Market Clinical Follow-up (PMCF) Evaluation Report
Post Market Clinical Follow-up (PMCF) Evaluation Report
- MS Word Format
- MDR 2017/745 Compliant
- EU Guidance Compliant
- Digital Content - Instant Download
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. This product helps manufacturers present post market clinical data to notified bodies and competent authorities in an organized format.
Post Market Clinical Follow-Up (PMCF) Evaluation Report - OverviewThe Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a PMCF plan and its evaluation report, necessary to its implementation.
Post Market Clinical Follow-Up (PMCF) Evaluation Report - ComplianceThe PMCF Evaluation Report template complies with MDR 2017/745
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Post Market Clinical Follow Up Plan
Post Market Clinical Follow-up (PMCF) Plan. User friendly, detailed guidance, The post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation and is made part of the manufacturer’s post-market surveillance (PMS) plan.
- MS Word Format
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Clinical Evaluation Procedure
The 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).
- MEDDEV 2.7/1 Rev 4 Compliant
- MDR (EU) 2017/745 Compliant
- ISO 13485:2016 Compliant
- MS Word Format
- Instant Download Digital Content
Post Market Surveillance Procedure
The Post Market Surveillance Procedure governs all post market surveillance activities and provides instruction on: Post Market Surveillance Plans and Reports; and Post Market Clinical Follow-Up (PMCF) requirements including easy to follow templates.
- MEDDEV 2.12/1 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- MS Word Format
- Instant Download Digital Content
Medical Device Quality Management System | MANUFACTURING PLUS
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 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!
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- 72 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
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