We build and optimize Quality Management Systems (QMS) that meet the stringent requirements of ISO 13485 and FDA 21 CFR Part 820 — ensuring your manufacturing operations are audit-ready and globally compliant.
Our consulting includes end-to-end system design, documentation architecture, supplier quality programs, and risk management per ISO 14971.
Whether you’re a startup seeking certification or an established manufacturer aiming for higher maturity, we help you establish a scalable QMS with controlled procedures, CAPA systems, internal audit programs, and training modules tailored to your device class and production environment.
We build and optimize Quality Management Systems (QMS) that meet the stringent requirements of ISO 13485 and FDA 21 CFR Part 820 — ensuring your manufacturing operations are audit-ready and globally compliant.
Our consulting includes end-to-end system design, documentation architecture, supplier quality programs, and risk management per ISO 14971.
Whether you’re a startup seeking certification or an established manufacturer aiming for higher maturity, we help you establish a scalable QMS with controlled procedures, CAPA systems, internal audit programs, and training modules tailored to your device class and production environment.
GAP assessment vs ISO 13485 / 21 CFR 820
Risk management per ISO 14971
Document control and traceability setup
Supplier quality & CAPA systems
Internal audit preparation
