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