• 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

Validation Protocols for Medical Device Manufacturers

VALIDATION PROTOCOLS

Injection Mold Validation Procedure

$149.00

$149.00

Ethylene Oxide (EO) Product Adoption Protocol

$149.00

$149.00

Software Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Final Cleaning Orthopedic Implants

$149.00

$149.00

Accelerated Aging Study

$149.00

$149.00

4 Sided Seal (4SS) Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

$199.00

Bar Sealer Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

$199.00

Tray Sealer Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

$199.00

4 Sided Seal (4SS) Operational Qualification OQ Protocol | Medical Device

$119.00

$119.00

4 Sided Seal (4SS) Performance Qualification PQ Protocol | Medical Device

$119.00

$119.00

Bar Sealer Operational Qualification OQ Protocol | Medical Device

$119.00

$119.00

Bar Sealer Performance Qualification PQ Protocol | Medical Device

$119.00

$119.00

Tray Sealer Operational Qualification OQ Protocol | Medical Device

$119.00

$119.00

Tray Sealer Performance Qualification PQ Protocol | Medical Device

$119.00

$119.00

Customer Requirements Validation Procedure

$149.00

$149.00

Medical Device Software Development Plan

$119.00

$119.00

Medical Device Clinical Investigation Plan

$49.00

$49.00

Medical Device Clinical Investigation Report

$49.00

$49.00