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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
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Design Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p21_i6_w640.jpeg)
Design Review Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
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Risk Management Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p40_i6_w640.jpeg)
Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
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Design Risk Management Procedure
$139.00
$139.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p51_i6_w2550.jpeg?width=640)
Process Risk Management Procedure
$139.00
$139.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p52_i5_w2550.jpeg?width=640)
Design Analysis Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p86_i3_w2550.jpeg?width=640)
Unique Device Identification Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p90_i2_w640.jpeg)
Clinical Evaluation Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p91_i4_w2550.jpeg?width=640)
Clinical Investigation Procedure
$199.00
$199.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p94_i2_w640.jpeg)
ISO 13485 Label Review and Approval Procedure
$139.00
$139.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p97_i2_w640.jpeg)
CE Marking Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p107_i3_w2550.jpeg?width=640)
Human Factors and Usability Engineering Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p53_i22_w640.jpeg)
Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p89_i6_w640.jpeg)
Post Market Surveillance Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p99_i5_w640.jpeg)
Injection Mold Validation Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p109_i1_w640.jpeg)
Ethylene Oxide (EO) Product Adoption Protocol
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p115_i1_w640.jpeg)
Software as a Medical Device (SaMD) Development Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p118_i1_w640.jpeg)
Software Clinical Evaluation Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p127_i1_w640.jpeg)
Customer Requirements Validation Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p129_i1_w640.jpeg)
Periodic Safety Update Report (PSUR) Procedure
$139.00
$139.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p144_i3_w640.jpeg)
Medical Device Product Performance Specification Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p148_i1_w640.jpeg)
Medical Device Process Validation Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p149_i3_w640.jpeg)
Medical Device Software Development Plan
$119.00
$119.00