Quality and regulatory consulting
Supporting medical device manufacturers and cleanroom teams with practical, experience-based consulting that strengthens quality systems and drives sustainable compliance.
Who we work with
We partner with organizations across the medical product lifecycle, from design and manufacturing through cleanroom operations.
From startups to established manufacturers, we help build and optimize electronic quality management systems (eQMS) aligned with 21 CFR 820 / QMSR and ISO 13485 to support successful product development, clearance, and sustained market presence.
Support for establishing and maintaining ISO 7 and ISO 8 cleanrooms. We help teams put environmental controls, monitoring, gowning, and documentation in place so classified spaces stay in a controlled, audit-ready state.
How we help
Led by an analytical professional with 20+ years of quality experience in product design and process, delivering solutions that work in real operating environments.
Deep expertise in medical device eQMS requirements, including 21 CFR 820, the evolving Quality Management System Regulation (QMSR), and ISO 13485.
We work collaboratively with your team, whether you need targeted gap assessments, full system design, training, or ongoing advisory support.
Experience supporting both emerging companies entering regulated markets and established organizations refining mature quality systems.