Quality Management Services
Quality is the foundation of every successful product launch. OneGlobal Trinity M Consulting helps medical device, pharmaceutical, and biotechnology companies build, implement, and maintain quality systems that meet global regulatory expectations and stand up to agency scrutiny.
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Quality Management Systems (QMS) Implementation
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We design and implement Quality Management Systems aligned with global regulatory standards — built to fit your operations, scale with your growth, and support both routine compliance and audit readiness.
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Full QMS implementation aligned with ISO 9001, ISO 13485, MDSAP, and FDA QMSR
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Custom QMS design tailored to your products, processes, and stage of growth
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Gap assessments to identify compliance risks and prioritize remediation
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Team training on QMS requirements, responsibilities, and best practices
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Transition support for organizations moving from FDA QSR to QMSR
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Document Management
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A well-structured document control system is the backbone of an effective QMS. We help clients establish document management practices that ensure traceability, version control, and audit readiness from day one.
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Industry-tested templates for QMS implementation and ongoing maintenance
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Template customization aligned with your products, processes, and regulatory scope
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Template integration with existing systems and workflows
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Document control system design, implementation, and optimization
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Internal Audits & Remediation
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We conduct internal audits, support agency inspections, and lead remediation efforts when findings emerge.
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Comprehensive internal audits aligned with ISO 13485, FDA QMSR, and MDSAP
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Mock FDA inspections and audit readiness assessments
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Corrective and Preventive Action (CAPA) development and implementation
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Non-conformance investigation and resolution
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Complaint management system design and ongoing support
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FDA Warning Letter and Form 483 response, remediation planning, and execution
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Recall management and post-market reporting
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