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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 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

Calibration System Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Technology Transfer Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00

Design Control Procedure 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

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

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

Accelerated Aging Study
$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) 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

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
$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