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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
$1,899.00
$1,899.00
Medical Device Quality Management System | BASE PLUS SYSTEM
$2,599.00
$2,599.00
Medical Device Design and Development Procedures
$2,499.00
$2,499.00
Medical Device Quality Management System | DESIGN PLUS
$3,199.00
$3,199.00
Medical Device Quality Management System | MANUFACTURING
$3,499.00
$3,499.00
Medical Device Quality Management System | MANUFACTURING PLUS
$4,499.00
$4,499.00
4 Sided Seal (4SS) Performance Qualification PQ Protocol | Medical Device
$199.00
$199.00
4 Sided Seal (4SS) Operational Qualification OQ Protocol | Medical Device
$199.00
$199.00
Tray Sealer Performance Qualification PQ Protocol | Medical Device
$199.00
$199.00
Tray Sealer Operational Qualification OQ Protocol | Medical Device
$199.00
$199.00
Bar Sealer Performance Qualification PQ Protocol | Medical Device
$199.00
$199.00
Bar Sealer Operational Qualification OQ Protocol | Medical Device
$199.00
$199.00
Calibration System Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Validation Protocol and Report Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Design Control Procedure Bundle | ISO 13485 | FDA QSR Compliant
$499.00
$499.00
Complaint Handling Procedures Bundle | ISO 13485 | FDA QSR Compliant
$499.00
$499.00
Risk Management Procedures Bundle | ISO 13485 | FDA QSR Compliant
$499.00
$499.00
Clinical Evaluation Procedure Bundle
$499.00
$499.00
Medical Device Software Procedure Bundle
$499.00
$499.00
Medical Device Labeling Procedure Bundle
$499.00
$499.00
ISO 13485 Document Control Procedure Bundle
$349.00
$349.00
Document Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Engineering Change Notice Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Management Review Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Training Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
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
$149.00
$149.00
Design Verification - Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Software as a Medical Device (SaMD) Development Procedure
$149.00
$149.00
Software Clinical Evaluation Procedure
$149.00
$149.00
Clinical Evaluation Procedure
$199.00
$199.00
Clinical Investigation Procedure
$149.00
$149.00
Software Validation Procedure | ISO 13485 | FDA QSR Compliant
$199.00
$199.00
Human Factors and Usability Engineering Procedure
$149.00
$149.00
Risk Management Procedure
$149.00
$149.00
Design Risk Management Procedure
$149.00
$149.00
Process Risk Management Procedure
$149.00
$149.00
Design Analysis Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Product Stability Shelf-Life Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Accelerated Aging Study
$149.00
$149.00
Biocompatibility - Toxicity Testing Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
ISO 13485 Label Review and Approval Procedure
$149.00
$149.00
Unique Device Identification Procedure
$149.00
$149.00
CE Marking Procedure
$149.00
$149.00
Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Ethylene Oxide (EO) Product Adoption Protocol
$149.00
$149.00
Injection Mold Validation Procedure
$199.00
$199.00
Supplier Management Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Medical Device Quality Agreement for US
$149.00
$149.00
Medical Device Quality Agreement for Europe
$149.00
$149.00
Installation Qualification IQ Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant
$49.00
$49.00
Identification Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Complaint Handling Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Complaint Trending Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
Remedial Action - Recall Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Corrective and Preventive Action Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Medical Device Report MDR Procedure | FDA QSR Compliant
$149.00
$149.00
Statistical Techniques Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Vigilance Procedure
$149.00
$149.00
Post Market Surveillance Procedure
$149.00
$149.00
Facility Inspection Procedure
$149.00
$149.00
Internal Audit Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
Product Hold Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
4 Sided Seal (4SS) Qualification Protocols Bundle OQ - PQ | Medical Device
$349.00
$349.00
Bar Sealer Qualification Protocols Bundle OQ - PQ | Medical Device
$349.00
$349.00
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