Quality
Quality Assurance
Providing Quality Support
Quality is critical for every project that Integrity Development works on We expect that the product we deliver meets all of your requirements and all of your expectations.
If you are a medical device company, we can provide you with the support you need for ISO 13485. We will work within your Quality Management System (QMS) or help you create your QMS by creating any documentation required for compliance. if needed, we will also guide you through Design Control and provide the documentation support you need to comply with FDA requirements. We will also provide you with training where needed.
QMS PHASE 1
Initiation of Product Development
Examples: Document Control SOP, Change Control SOP, Design Control SOP, Risk Management SOP, Design Review SOP, Design Control Training, Risk Management Training, Document and change Control Training.
QMS PHASE 2
Initiation of Post Design Input Development
Examples: Software Development SOP, Training SOP, Supplier Qualification SOP, Software and Electronic Data Validation SOP, Statistical Technical SOP, Personnel Qualification Assurance SOP, Control of R&D Measuring Equipment, Equipment Calibration Log, Requirements Traceability Matrix Template, Quality Manual.
QMS PHASE 3
Prep for Production of Product for Verification/Validation
Examples: Production and Process Controls SOP, Materials Control SOP, Process Validation Procedures, Product Validation SOP, Product Verification Procedure, Inspection Procedure, Inspection SOP.
QMS PHASE 4
Prep for Design Transfer
Examples: Management Review SOP, Labeling SOP, Rework SOP, CAPA SOP, Nonconformance SOP, Product Distribution SOP, Record Retention SOP, DMR, DHR, SOP, Compliant SOP, Medical Device Report and Vigilance SOP, Service Procedure, Post Market Surveillance SOP.
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