Quality Assurance and Regulatory Affairs

Quality Management Systems (QMS) & Regulatory Audits

Empowering MedTech Innovators with Robust QMS Solutions

An effective Quality Management System (QMS) is fundamental to every stage of the medical device lifecycle. Regulatory frameworks such as ISO 13485:2016, MDSAP, US FDA 21 CFR Part 820, and region-specific requirements mandate robust quality systems to ensure safety and performance.
We offer comprehensive QMS consulting and implementation support tailored to the specific needs of MedTech manufacturers.

QMS Advisory & Implementation

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Guidance and execution support for standards including:

ISO 13485:2016
US FDA 21 CFR Part 820
MDSAP, KGMP, BGMP
MDR 2017 (India), QSD (Taiwan), MHLW MO169 (Japan)

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Gap assessments and QMS remediation

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Risk management consulting based on ISO 14971

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QMS lifecycle management for startups

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Review and updates of QMS documentation

Audit Support

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QMS compliance (ISO 13485, MDSAP, FDA, etc.) and audit support (internal, supplier, and third-party audits)

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CAPA (Corrective and Preventive Action) full lifecycle support: Root cause analysis (RCA), verification, and closure

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Supplier evaluation and audits

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QMS toolkit deployment

Get end-to-end QMS and audit support tailored to global MedTech standards.

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