1733 Canton Ln.
Marietta,
GA 30062-2679 us
Tel: 770-565-6166
Fax: 770-565-9762
Contact: Ron Arkin
Year Established: 1994
No. of Employees: 6Provides strategic regulatory, consulting, submissions, QA, and compliance services, including QSR, GxP, ISO, QSIT, and design control audits, training, and consulting; 510(k) and IDE/PMA submissions; validations; process improvement; and response/resolutions for 483s, warning letters, MDR, and recall. Also offered is development of quality systems for FDA, ISO 9000:2000, ISO 13485, and CE mark requirements.