Quality Management Systems
A robust Quality Management System (QMS) is crucial for ensuring the safety, efficacy, and quality of medical devices, and for maintaining compliance with regulatory requirements.
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A QMS in the context of medical devices is a structured system of procedures and processes covering all aspects of the device lifecycle, from design and development to production, distribution, and post-market activities.
At SageMar Medical, we design, implement, and optimize Quality Management Systems tailored to your specific needs, ensuring adherence to international standards such as ISO 13485 and FDA regulations. ​Our services also include conducting audits and training staff to maintain compliance and improve product quality.
Compliance with Standards
Document Control
Design Controls
Supplier Management
Production and Process Controls
Corrective and Preventative Actions
Audits
Training and Competence
Risk Management
Post-Market Surveillance
