• 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 8 | Measurement Analysis Improvement

ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT PROCEDURES

Customer Requirements Validation Procedure

$149.00

$149.00

Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Complaint Trending Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

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

$149.00

$149.00

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

$149.00

$149.00

Internal Audit Procedure | ISO 13485 | FDA QSR Compliant

$99.00

$99.00

Medical Device Report MDR Procedure | FDA QSR Compliant

$149.00

$149.00

Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Product Hold Procedure | ISO 13485 | FDA QSR Compliant

$149.00

$149.00

Vigilance Procedure

$149.00

$149.00

Post Market Surveillance Procedure

$149.00

$149.00

Periodic Safety Update Report (PSUR) Procedure

$139.00

$139.00

Failure Investigation Procedure

$149.00

$149.00

Post Market Clinical Follow Up Plan

$49.00

$49.00

Post Market Clinical Follow-up (PMCF) Evaluation Report

$49.00

$49.00