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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
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Quality System Products | ISO 13485 | FDA QSR Compliant
Our ISO 13485:2016 quality system procedures provide solutions for medical device companies needing to address ISO 13485:2016, FDA QSR, or MDR EU 2017/745 compliance "gaps" For more information please contact us at [email protected]
![](/uploads/6/5/2/5/65256395/s280509067325387815_p131_i11_w640.jpeg)
Medical Device Quality Management System | BASE SYSTEM
$1,499.00
$1,499.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p133_i11_w640.jpeg)
Medical Device Quality Management System | BASE PLUS SYSTEM
$1,799.00
$1,799.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p134_i10_w640.jpeg)
Medical Device Design and Development Procedures
$1,899.00
$1,899.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p138_i9_w640.jpeg)
Medical Device Quality Management System | DESIGN PLUS
$2,699.00
$2,699.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p139_i11_w640.jpeg)
Medical Device Quality Management System | MANUFACTURING
$2,899.00
$2,899.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p141_i18_w640.jpeg)
Medical Device Quality Management System | MANUFACTURING PLUS
$3,599.00
$3,599.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p85_i25_w640.jpeg)
Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant
$499.00
$499.00
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Clinical Evaluation Procedure Bundle
$499.00
$499.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p116_i1_w640.jpeg)
Medical Device Software Procedure Bundle
$449.00
$449.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p117_i1_w640.jpeg)
Medical Device Labeling Procedure Bundle
$449.00
$449.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p96_i13_w640.jpeg)
ISO 13485 Document Control Procedure Bundle
$399.00
$399.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p11_i3_w640.jpeg)
Document Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p17_i4_w640.jpeg)
Management Review Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p19_i6_w640.jpeg)
Training Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p20_i10_w640.jpeg)
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
![](/uploads/6/5/2/5/65256395/s280509067325387815_p40_i6_w640.jpeg)
Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
$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_p90_i2_w640.jpeg)
Clinical Evaluation 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_p107_i3_w2550.jpeg?width=640)
Human Factors and Usability Engineering Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p22_i10_w2550.jpeg?width=640)
Risk Management Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p50_i5_w2550.jpeg?width=640)
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_p94_i2_w640.jpeg)
ISO 13485 Label Review and Approval Procedure
$139.00
$139.00
![](/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_p97_i2_w640.jpeg)
CE Marking 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_p25_i6_w640.jpeg)
Supplier Management Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p26_i3_w640.jpeg)
Identification Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p30_i3_w640.jpeg)
Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p57_i4_w640.jpeg)
Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p62_i3_w640.jpeg)
Medical Device Report MDR Procedure | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p63_i2_w640.jpeg)
Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p64_i4_w640.jpeg)
Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p88_i1_w640.jpeg)
Vigilance Procedure
$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_p106_i1_w640.jpeg)
Facility Inspection Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p61_i5_w640.jpeg)
Internal Audit Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p66_i3_w640.jpeg)
Product Hold Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p121_i1_w640.jpeg)
Cleanroom Procedure Bundle
$249.00
$249.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p87_i6_w640.jpeg)
ISO 13485 Quality Management System Manual
$139.00
$139.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p93_i2_w640.jpeg)
First Article Inspection Procedure
$49.00
$49.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p95_i2_w640.jpeg)
ISO 13485 Contract Review Procedure
$49.00
$49.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p102_i1_w640.jpeg)
Respiratory Protection Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p103_i1_w640.jpeg)
Biohazard Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p104_i1_w640.jpeg)
Lockout - Tagout Procedure
$149.00
$149.00
![](/uploads/6/5/2/5/65256395/s280509067325387815_p108_i2_w640.jpeg)
Line Clearance Procedure
$49.00
$49.00
![](/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_p128_i1_w640.jpeg)
Device History Record 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_p130_i1_w640.jpeg)
Failure Investigation Procedure
$149.00
$149.00
![](/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_p146_i3_w640.jpeg)
Medical Device Sterilization Procedure Bundle
$399.00
$399.00