A.P. LYON
  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
  • ABOUT
  • CONTACT
  • STORE
  • >
  • ISO 13485 QUALITY SYSTEM PROCEDURES
  • >
  • ISO 13485 PRODUCT REALIZATION PROCEDURES
  • >
  • ISO 13485 DESIGN DEVELOPMENT PROCEDURES
  • >
  • Clinical Evaluation Procedure

Clinical Evaluation Procedure

SKU: SOP 7-038
$149.00
$149.00
Unavailable
per item

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
  • Facebook
  • Twitter
  • Pinterest
  • Google+
Add to Cart

Clinical Evaluation Procedure

The Clinical Evaluation Procedure governs the entire clinical evaluation process. MEDDEV 2.7/1 Rev 4, MDR EU 2017/745, FDA QSR and ISO 13485:2016 compliant. ​

Clinical Evaluation Procedure Overview

The Clinical Evaluation Procedure provides detailed instruction on:
  • defining the scope of a clinical evaluation;
  • identification of pertinent data and literature reviews;
  • appraisal of pertinent data; analysis of clinical data;
  • generating a Clinical Evaluation Report (CER). The procedure includes an instructive CER report template with guidance for each section. ​
  • ​conducting Post Market Clinical Follow-Up (PMCF)
​The Clinical Evaluation Procedure also provides detailed instruction on Post Market Clinical Follow-up (PMCF). ​

Clinical Evaluation Procedure Compliance

​The clinical evaluation procedure is MEDDEV 2.7/1 Rev 4, MDR EU 2017/745, and ISO 13485:2016 compliant.​
For  more information about our Clinical Evaluation Procedure contact us at info@aplyon.com

RELATED LINKS

​​Clinical Evaluation Procedure Bundle
Clinical Investigation Procedure
Post Market Surveillance Procedure
​CE Marking Procedure
Software Clinical Evaluation Procedure
Clinical Evaluation Procedure
Clinical Evaluation Procedure

Customer's also viewed

Clinical Evaluation Procedure Bundle

$499.00

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. ​​


  • ​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
view

Clinical Investigation Procedure

$199.00
The Clinical Investigation Procedure complies with ISO 14155:2020. 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.
  • ISO 14155:2020 Compliant
  • MDR EU 2017/745 Compliant
  • ​ISO 13485:2016 Compliant
  • Includes Multiple Forms
  • ​MS Word Format
  • ​Instant Download Digital File
view

Medical Device Quality Management System | DESIGN PLUS

$2,699.00

The DESIGN PLUS Quality Management System (QMS) is configured for companies engaged in research and development of medical devices but perform no manufacturing (Specification Developers). The Design Plus QMS system is configured for companies desiring ISO 13485:2016 certification and FDA QSR compliance. Products installed in 46 countries and growing!​

  • Quality Management System Manual
  • 46 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download 
view

Medical Device Quality Management System | MANUFACTURING PLUS

$3,599.00

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!​

  • Quality Management System Manual
  • 72 Procedures and Related Forms (MS Word and Excel)
  • ISO 13485:2016 and FDA QSR Compliant
  • MDR EU 2017/745 Compliant​​​​​
  • Digital Content - Instant Download ​
view

HOME

STORE

CONSULTING

PRIVACY POLICY

CONTACT

TERMS / CONDITIONS
Copyright © 2010-2023
  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
  • ABOUT
  • CONTACT