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End to End Quality Assurance Solutions
Mission
Mission
Our mission is to apply vast industry experience to meet and exceed your Quality Assurance needs.
Standard Services
Quality Assurance
Quality Assurance
-QMS creation and support
-Audits: QSIT, EU MDR, MDSAP, Due Diligence, Internal, etc.
-Remediation: FDA 483s, Warning Letters, Consent Decrees, NB Observations
-Training and Education
-Post Market Surveillance (annual and ongoing)
Regulatory Affairs
Regulatory Affairs
-Strategy, Registrations and Agency Communications
-Global Submission: 510(k), DeNovo, PMA, PMA Supplemants, EU MDR Technical Documentation
-Due Diligence, Labelling, Marketing Material
Clinical Affairs
Clinical Affairs
-Study Design and Protocols
-CER/PER, Clinical Submissions
Clinical Audits, Trial Reports, Trial Management
Quality Engineering
Quality Engineering
-Risk Management (ISO 14971)
Design Control: DHF development and remediation, Software Development Life Cycle (IEC 62304), Usability (IEC 62366)
-Validation: eQMS, Process, Product, Facility, etc.
Questions?
Questions?
Contact daniel@g2qaconsulting.com to get more information on the project
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