• ISO 13485 QUALITY SYSTEMS
• ISO 13485 PROCEDURE BUNDLES
• ISO 13485 QUALITY SYSTEM PROCEDURES
  • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES
  • ISO 13485 MANAGEMENT RESPONSIBILITY PROCEDURES
  • ISO 13485 RESOURCE MANAGEMENT PROCEDURES
  • ISO 13485 PRODUCT REALIZATION PROCEDURES
    • ISO 13485 DESIGN DEVELOPMENT PROCEDURES
    • ISO 13485 PURCHASING PROCEDURES
    • ISO 13485 PRODUCTION SERVICE PROVISION PROCEDURES
    • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES
  • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT PROCEDURES
• VALIDATION PROTOCOLS
• CONTRACTS - AGREEMENTS

ISO 13485 Quality Management Systems | Section 7 | Product Realization | FDA QSR Compliant

ISO 13485 PRODUCT REALIZATION PROCEDURES

Risk Management Procedure

$149.00

$149.00

Design Risk Management Procedure

$139.00

$139.00

Process Risk Management Procedure

$139.00

$139.00

Design Control Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Human Factors and Usability Engineering Procedure

$149.00

$149.00

Clinical Evaluation Procedure

$149.00

$149.00

Clinical Investigation Procedure

$199.00

$199.00

Design Review Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Design Analysis Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Design Transfer Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Product Stability Shelf-Life Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Design Verification - Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Supplier Management Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Identification Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Calibration System Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Software Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

ISO 13485 Label Review and Approval Procedure

$139.00

$139.00

ISO 13485 Contract Review Procedure

$49.00

$49.00

CE Marking Procedure

$149.00

$149.00

Post Market Surveillance Procedure

$149.00

$149.00

Software as a Medical Device (SaMD) Development Procedure

$149.00

$149.00

Software Clinical Evaluation Procedure

$149.00

$149.00

Cleanroom Design and Validation Procedure

$149.00

$149.00

Customer Requirements Validation Procedure

$149.00

$149.00

Device History Record Procedure

$149.00

$149.00

Periodic Safety Update Report (PSUR) Procedure

$139.00

$139.00

Failure Investigation Procedure

$149.00

$149.00

Purchase Order Procedure | ISO 13485

$99.00

$99.00

Medical Device Product Performance Specification Procedure

$149.00

$149.00

ISO 13485 Process Validation Procedure Bundle

$399.00

$399.00

Medical Device Process Validation Procedure

$149.00

$149.00

Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant

$119.00

$119.00

Medical Device Clinical Investigation Plan

$49.00

$49.00

Medical Device Clinical Investigation Report

$49.00

$49.00