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Quality Management Systems

Overview

Fusion strengthens organizations by developing, optimizing, and supporting robust Quality Management Systems that meet global regulatory expectations. Our specialists design and implement QMS frameworks aligned with ISO standards, FDA regulations, GxP principles, and industry-specific compliance mandates. We assist in creating SOPs, managing change control, conducting gap assessments, and preparing for internal or external audits. Fusion also provides ongoing quality engineering support, including CAPA investigations, nonconformance management, risk assessments, and supplier quality oversight. Our approach focuses on building sustainable systems that simplify compliance, improve process discipline, and enhance product quality. With deep experience across life sciences, medical devices, and manufacturing, Fusion helps clients create quality ecosystems that withstand regulatory scrutiny and support long-term operational excellence.

Compliance with

ISO Standards
FDA Regulations
21 CFR
GAMP
IEC Standards

Capabilities

Quality System Support
Audits & Inspection Readiness
CAPA, Risk Management, FMEA
Documentation & Regulatory Alignment

We do not just provide talent

We provide capability, problem-solving, and services — with speed and cost-efficiency at the core

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