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ISO 13485 QUALITY SYSTEMS
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ISO 13485 PROCEDURE BUNDLES
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ISO 13485 QUALITY SYSTEM PROCEDURES
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VALIDATION PROTOCOLS
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CONTRACTS - AGREEMENTS
ISO 13485 Quality Management Systems | Section 7.3 | Design and Development | FDA QSR Compliant
ISO 13485 DESIGN DEVELOPMENT PROCEDURES

Design Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Design Review Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Risk Management Procedure
$149.00
$149.00

Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Design Risk Management Procedure
$139.00
$139.00

Process Risk Management Procedure
$139.00
$139.00

Design Analysis Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Unique Device Identification Procedure
$149.00
$149.00

Clinical Evaluation Procedure
$149.00
$149.00

Clinical Investigation Procedure
$199.00
$199.00

ISO 13485 Label Review and Approval Procedure
$139.00
$139.00

CE Marking Procedure
$149.00
$149.00

Human Factors and Usability Engineering Procedure
$149.00
$149.00

Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Post Market Surveillance Procedure
$149.00
$149.00

Injection Mold Validation Procedure
$149.00
$149.00

Ethylene Oxide (EO) Product Adoption Protocol
$149.00
$149.00

Software as a Medical Device (SaMD) Development Procedure
$149.00
$149.00

Software Clinical Evaluation Procedure
$149.00
$149.00

Customer Requirements Validation Procedure
$149.00
$149.00

Periodic Safety Update Report (PSUR) Procedure
$139.00
$139.00

Medical Device Product Performance Specification Procedure
$149.00
$149.00

Medical Device Process Validation Procedure
$149.00
$149.00

Medical Device Software Development Plan
$119.00
$119.00