Kapitol Group International (KGI) is an IVD solutions provider headquartered in Taiwan. Our internal operating model emphasizes quality discipline, regulatory alignment, engineering rigor, and dependable execution across a global supply chain. We prioritize long-term credibility over short-term volume.

How We Operate

1) Quality-first decision making
We design, source, and deliver diagnostic products under a “quality-by-design” mindset—driven by risk management, traceability, and continuous improvement.

2) Regulatory alignment as standard practice
We treat regulatory documentation and technical evidence as part of the product itself. Our internal processes are built to support dossier readiness (e.g., IFU consistency, performance evidence, change control, labeling, and post-market documentation).

3) Engineering and service accountability
We support partners with clear technical communication, structured troubleshooting, and practical after-sales service to ensure reliable field performance.

4) Supply chain discipline
We maintain controlled specifications, defined acceptance criteria, and supplier governance to reduce variability and ensure consistent delivery.

Internal Standards & Controls

• Document control and version management

• Change control and design transfer discipline

• Supplier qualification and incoming inspection criteria

• Nonconformance, CAPA, and complaint handling workflow

• Training records and role-based competency requirements

• Traceability and release management for shipment readiness

Our Culture

We operate with a pragmatic, data-driven mindset:

• Be precise with facts and records

• Communicate clearly and directly

• Solve problems systematically (root cause over assumptions)

• Protect partner trust by doing the right thing, consistently