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Quality management

Implementation and Revitalization of the Quality Management System.

Certificate of Good Manufacturing Practices.

Certificate of Good Distribution and Storage Practices.
ISO 13485 certification.

Treatment of non-conformities, Corrective Actions and Preventive Actions.

Critical Analysis of the Quality Management System.

Audit.

Regulatory Requirements

Interpretation of regulatory requirements of national and international standards.

Adequacy of processes to meet standards.

Adequacy of Technical Dossier to meet requirements.

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Request a Proposal Leaders in the field of health product certification, Quality Management System implementation, revitalization and more. Regulatory Affairs

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Request a Proposal

Leaders in the field of health product certification,
Quality Management System implementation, revitalization and more.
Regulatory Affairs