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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 quickly address an ISO 13485:2016, FDA QSR or MDR EU 2017/745 compliance "gap". For more information about our products and services please contact us at info@apylon.com
Medical Device Quality Management System | BASE SYSTEM
$1,499.00
$1,499.00
Medical Device Quality Management System | BASE PLUS SYSTEM
$1,799.00
$1,799.00
Medical Device Design and Development Procedures
$1,899.00
$1,899.00
Medical Device Quality Management System | DESIGN PLUS
$2,699.00
$2,699.00
Medical Device Quality Management System | MANUFACTURING
$2,899.00
$2,899.00
Medical Device Quality Management System | MANUFACTURING PLUS
$3,599.00
$3,599.00
Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant
$399.00
$399.00
Clinical Evaluation Procedure Bundle
$449.00
$449.00
Medical Device Software Procedure Bundle
$399.00
$399.00
Medical Device Labeling Procedure Bundle
$399.00
$399.00
ISO 13485 Document Control Procedure Bundle
$249.00
$249.00
Document Control Procedure | ISO 13485 | FDA QSR Compliant
$129.00
$129.00
Management Review Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Training Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Design Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Design Review Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Design Transfer Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Software as a Medical Device (SaMD) Development Procedure
$119.00
$119.00
Software Clinical Evaluation Procedure
$119.00
$119.00
Clinical Evaluation Procedure
$129.00
$129.00
Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$129.00
$129.00
Human Factors and Usability Engineering Procedure
$129.00
$129.00
Risk Management Procedure
$129.00
$129.00
Design Risk Management Procedure
$129.00
$129.00
Process Risk Management Procedure
$129.00
$129.00
Design Analysis Procedure | ISO 13485 | FDA QSR Compliant
$129.00
$129.00
ISO 13485 Label Review and Approval Procedure
$119.00
$119.00
Unique Device Identification Procedure
$149.00
$149.00
CE Marking Procedure
$149.00
$149.00
Injection Mold Validation Procedure
$149.00
$149.00
Supplier Management Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Identification Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
$129.00
$129.00
Medical Device Report MDR Procedure | FDA QSR Compliant
$119.00
$119.00
Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant
$129.00
$129.00
Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Vigilance Procedure
$119.00
$119.00
Post Market Surveillance Procedure
$139.00
$139.00
Facility Inspection Procedure
$119.00
$119.00
Internal Audit Procedure | ISO 13485 | FDA QSR Compliant
$69.00
$69.00
Product Hold Procedure | ISO 13485 | FDA QSR Compliant
$119.00
$119.00
Cleanroom Procedure Bundle
$249.00
$249.00
ISO 13485 Quality Management System Manual
$139.00
$139.00
First Article Inspection Procedure
$49.00
$49.00
ISO 13485 Contract Review Procedure
$49.00
$49.00
Respiratory Protection Procedure
$119.00
$119.00
Biohazard Procedure
$119.00
$119.00
Lockout - Tagout Procedure
$119.00
$119.00
Line Clearance Procedure
$39.00
$39.00
Customer Requirements Validation Procedure
$119.00
$119.00
Device History Record Procedure
$119.00
$119.00
Periodic Safety Update Report (PSUR) Procedure
$119.00
$119.00
Failure Investigation Procedure
$129.00
$129.00
Medical Device Product Performance Specification Procedure
$119.00
$119.00
Medical Device Sterilization Procedure Bundle
$399.00
$399.00