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Quality Assurance
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When you make quality a habit, you quality into your product and company from day one.
QMS Development
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Quality Plan, SOPs, and Forms
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Full Quality Management System (QMS) Development
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QMS Training
QMS Alignment
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Combination Products
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Post M&A
QMS Record Remediation
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Corrective and Preventive Actions (CAPA)
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Complaints
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Design History File (DHF)
Audit Support
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QMS Audits
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Gap Assessment
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Pre-Approval Inspection
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Verification Audit
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Certification Preparation Audit
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Mock FDA Inspection
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MSDAP Preparation
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ISO 13485 Audit Preparation
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Supplier Audit
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Due Diligence Audit
QMS Maintenance
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CAPAs
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Complaint Handling
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Adverse Event Reporting
R&D Support
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Quality Control (QC) Support During Product Development
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QC Manufacturing Support & Training
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