Quality Management System -

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Quality Management System (QMS)

QMS that complies with EU MDR, ISO 13485 & FDA 21 CFR 820

Manage and control documentation to ensure accuracy, accessibility and traceability.

Development of complete ISO 14971 medical device risk management document.

Assessing and monitoring supplier performance to ensure quality and compliance of supplied materials.

Complaint handling, Adverse event reporting.

Monitoring product performance and safety post-approval to ensure ongoing compliance.

Evaluate and monitor suppliers to guarantee quality of materials and components.

Non-Conformance & CAPA management.

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