A robust quality system is the foundation of trust with regulators. Without it, even well supported drugs and devices can face delays, findings, or failures. Problems often start when quality is treated as a box-checking exercise or built from generic templates that do not reflect how work is actually done. The result is a system that looks acceptable on paper but is hard to follow in practice and fragile under FDA or global authority review. An effective quality system must meet regulatory requirements while remaining usable for the people who rely on it, create clarity about roles and decision rights, and generate records that reliably tell the story of how products are developed, tested, and released.
HIC designs and implements quality systems that are both aligned with FDA, ISO, and other regulatory expectations and practical. Our teams include former FDA investigators and experienced industry quality leaders who have run global programs and managed real inspections. We work with you to understand current operations, identify gaps and duplications, and build processes that align with FDA, ISO, and other health authority expectations without adding unnecessary complexity. Implementation support includes documentation, training, and change management, so the system is adopted across functions and not left on a shelf. The result is a quality system that is designed to be embedded in daily operations, inspection-ready and scalable.
Quality systems that perform under inspection
- Our team includes former FDA quality leaders with direct experience evaluating and defending systems during inspections
- We design quality structures that meet ISO 13485, MDSAP, and 21 CFR requirements while avoiding needless layers and bureaucracy
- Frameworks are tailored to the size, maturity, and capabilities of your organization so procedures can be followed consistently, not worked around
- We guide implementation, training, and ongoing refinement to ensure the quality system performs in real operations, not just in written procedures
