• ISO 13485 QUALITY SYSTEMS
• 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

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Quality System Products | ISO 13485 | FDA QSR Compliant

Our ISO 13485:2016 quality system procedures provide solutions for medical device companies needing to quickly address an ISO 13485:2016, FDA QSR or MDR EU 2017/745 compliance "gap". For more information about our products and services please contact us at info@apylon.com

ISO 13485 Quality System Manufacturers | FDA QSR Compliant

$3,799.00

$3,799.00

ISO 13485 Quality System Specification Developers | FDA QSR Compliant

$3,199.00

$3,199.00

Quality System Initial Importers | FDA QSR Compliant

$749.00

$749.00

Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant

$599.00

$599.00

Complaint Handling Procedures Bundle | ISO 13485 | FDA QSR Compliant

$399.00

$399.00

Risk Management Procedures Bundle | ISO 13485 | FDA QSR Compliant

$499.00

$499.00

Document Control Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Management Review Procedure | ISO 13485 | FDA QSR Compliant

$129.00

$129.00

Design Control Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Design Review Procedure | ISO 13485 | FDA QSR Compliant

$129.00

$129.00

Risk Management Procedure

$199.00

$199.00

Supplier Management Procedure | ISO 13485 | FDA QSR Compliant

$129.00

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Process Validation Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Identification Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Training - Job Descriptions Procedure | ISO 13485 | FDA QSR Compliant

$169.00

$169.00

Calibration System Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant

$99.00

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Engineering Change Notice Procedure | ISO 13485 | FDA QSR Compliant

$199.00

$199.00

Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant

$129.00

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

$69.00

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Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant

$99.00

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Design Transfer Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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

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ISO 13485 Quality System for Contract Manufacturers

$2,795.00

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Clinical Evaluation Procedure Bundle

$499.00

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Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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

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

$69.00

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Design Risk Management Procedure

$199.00

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Process Risk Management Procedure

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Design Analysis Procedure | ISO 13485 | FDA QSR Compliant

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Software Validation Procedure | ISO 13485 | FDA QSR Compliant

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

$199.00

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

$199.00

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

$199.00

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Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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Complaint Trending Procedure | ISO 13485 | FDA QSR Compliant

$99.00

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Remedial Action - Recall Procedure | ISO 13485 | FDA QSR Compliant

$149.00

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Corrective and Preventive Action Procedure | ISO 13485 | FDA QSR Compliant

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Medical Device Report MDR Procedure | FDA QSR Compliant

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Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant

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Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant

$119.00

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Unique Device Identification Procedure

$149.00

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ISO 13485 Quality Management System Manual

$99.00

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Vigilance Procedure

$99.00

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Post Market Surveillance Procedure

$149.00

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Clinical Evaluation Procedure

$199.00

$199.00

Clinical Investigation Procedure

$199.00

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ISO 13485 Label Review and Approval Procedure

$129.00

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ISO 13485 Document Control Procedure Bundle

$399.00

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CE Marking Procedure

$149.00

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Preventive Maintenance Procedure

$119.00

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Injection Mold Validation Procedure

$199.00

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Final Cleaning Orthopedic Implants

$199.00

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Accelerated Aging Study

$199.00

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Respiratory Protection Procedure

$199.00

$199.00

Biohazard Procedure

$199.00

$199.00

Lockout - Tagout Procedure

$149.00

$149.00

Facility Inspection Procedure

$149.00

$149.00