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Medical Device Software Procedure Bundle

SKU: MDSBNDL
$399.00
$399.00
Unavailable
per item

The Medical Device Software Procedure Bundle includes procedures related to development of software products, validation of software, software clinical evaluation, and how to apply human factors and usability engineering to the medical device development process. Also includes Medical Device Software Development Plan.

  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MS Word Format
  • ​Digital Content - Instant Download
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Medical Device Software Procedure Bundle

The Medical Device Software Procedure Bundle includes procedures related to development of Software and SaMD products, validation of software, and software clinical evaluation.

Medical Device Software Procedure Bundle - Contents

The Medical Device Software Procedure Bundle includes the following procedures:

Software as a Medical Device (SaMD) Development Procedure
-The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes. ​

Software Validation Procedure -The Software Validation Procedure establishes the requirements for computer systems and software used in medical device development and production, and post-distribution QA activities to ensure they have been validated for their intended use. ​

​Human Factors and Usability Engineering Procedure -The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists in following appropriate human factors and usability engineering processes to ensure new medical devices will be safe and effective for the intended uses and environments. ​ ​

Software Clinical Evaluation Procedure -The Software as a Medical Device Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance. ​
​
Medical Device Software Development Plan - The Software Development Plan addresses content contained within IEC 62304:2015, IEC 12207 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed.

Medical Device Software Procedure Bundle - Compliance

The Medical Device Software Procedure comply with ISO 13485:2016, IEC62304:2015, and 21 CFR Part 820.

​​​For more information about our Medical Device Software Procedure Bundle product please contact us at info@aplyon.com 

RELATED LINKS

Document Control Procedure Bundle
Design Control Procedure Bundle
​Risk Management Procedure Bundle
Clinical Evaluation Procedure Bundle
Medical Device Software Procedure Bundle
​Complaint Handling Procedure Bundle
​Cleanroom Procedure Bundle

Software Procedure Bundle Contents

software development procedure
Software Development
usability engineering procedure
Usability Engineering
software development plan
Software Development Plan
software validation procedure
Software Validation
software clinical evaluation procedure
Clinical Evaluation

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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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