Medical Device Quality & Regulatory Affairs Consulting
We help medical device companies in the US and the EU build compliant quality systems, clear regulatory submissions and stay audit-ready — so products reach patients without delay.
Two halves, listening. The mark begins with attention — obstacles heard before they're removed. Avighna means without obstacles.
A mark of insight, set where clarity begins.
Quality, verified. The open channel down the middle is the clear path we build for you.
ISO 13485 and US QMSR implementation and maintenance.
CDSCO MDR 2017, US FDA 510(k), EU MDR/IVDR.
ISO 14971, FMEA, IEC 62366 usability engineering.
Internal audits, mock inspections, and documentation that holds up under a regulator's eye.
DHF, V&V, IQ/OQ/PQ across the product lifecycle.
Corrective action systems and ongoing market monitoring.
Gap analysis against the standards and markets you target.
A prioritized roadmap with owners and dates.
Hands-on build-out of your QMS and submission package.
Ongoing audits, CAPA and surveillance to stay compliant.
Avighna QA Consulting also sources quality and regulatory affairs professionals for device companies hiring in the US. See the full talent page for the client and candidate tracks.
Visit the talent page