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          • 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
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          • Calibration System Procedure
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      • Clinical Investigation Report
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      • Injection Mold Validation Procedure
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      • Final Cleaning Orthopedic Implants
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  • Medical Device Sterilization Procedure Bundle

Medical Device Sterilization Procedure Bundle

SKU: STERILE-BNDL
$399.00
$399.00
Unavailable
per item
The Medical Device Sterilization Procedure Bundle includes QMS procedures related to EO and Gamma Sterilization Validation and Monitoring, Sterile Load Preparation and Release, and Environmental Controls. All of the procedures comply with ISO 13485:2016, ISO 11135:2014, ISO 11137-1,-2 and -3, and 21 CFR Part 820.
  • ISO 13485:2016 Compliant
  • ISO 1135 Compliant
  • ISO 11137 Compliant
  • 21 CFR Part 820 Compliant
  • MS Word Format
  • ​Digital Product - Instant Download
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Medical Device Sterilization Procedure Bundle

​The Medical Device Sterilization Procedure Bundle includes QMS procedures related to EO and Gamma Sterilization Validation and Monitoring, Sterile Load Preparation and Release, and Environmental Controls. 

Medical Device Sterilization Procedure Bundle - Content

Ethylene Oxide (EO) Sterilization Validation Procedure-The Ethylene Oxide (EO) Sterilization Validation Procedure defines the planning and testing requirements for conducting the validation, re-validation, adoption and routine sterilization of medical devices by ethylene oxide (EO) gas.
Gamma Irradiation Sterilization Validation Procedure-​The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The gamma sterilization validation procedure applies to all medical devices sterilized by gamma radiation.
Sterile Load Preparation and Release Procedure-The Sterile Load Preparation and Release Procedure governs the preparation and organization of a sterile load, the inspection of post-sterilized product, and the final release of a sterile load for commercial distribution. 
Environmental Controls Procedure-​The Environmental Controls Procedure provides establishes the requirements for cleanrooms and controlled manufacturing environments where a cleanliness standard is intended to be met or where other requirements for the manufacture of medical devices are necessary. 

Medical Device Sterilization Procedure Bundle - Compliance

The Medical Device Sterilization Procedure Bundle complies with ISO 13485:2016, ISO 11135:2014, ISO 11137-1,-2 and -3, ISO 11737, AAMI 14, 19 and 28, and 21 CFR Part 820.

RELATED LINKS

Design Control Procedure Bundle
​Risk Management Procedure Bundle
Clinical Evaluation Procedure Bundle
Complaint Handling Procedure Bundle
Medical Device Labeling Procedure Bundle
​Medical Device Software Procedure Bundle
​Document Control Procedure Bundle
​Cleanroom Procedure Bundle
EO sterilization Validation Procedure
EO Sterilization Validation Procedure
Sterile Load Preparation and Release Procedure
Sterile Load Preparation and Release Procedure
gamma sterilization procedure
Gamma Sterilization Validation Procedure
environmental controls procedure
Environmental Controls Procedure

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  • 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
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