Business type
Consultancy

Areas of operation
All regions

Company description
We provide strategic regulatory, consulting, submissions, QA and compliance services. Services include QSR, GxP, ISO, QSIT, and Design Control audits, training and consulting; 510(k) and IDE/PMA submissions; validation (process, software); process improvement; and response/resolutions for 483’s, Warning Letter, MDR, and recall. Also offered is development of Quality Systems for FDA, ISO 9000-2000, EN/ISO 13485 and CE mark requirements.