Oriel STAT A MATRIX has provided regulatory training and consulting to life science organizations since 1977. Our services include a comprehensive RA/QA training curriculum; transition support for MDSAP, EU MDR and IVDR; Technical Documentation development including CER’s; FDA strategic planning; 510(k), PMA, and other regulatory submissions; FDA 483 review and Warning Letter response; QSR/cGMP and ISO 13485 quality system implementation; baseline, supplier, and preassessment audits; process/software validation; and Lean Six Sigma.
1095 Morris Avenue
103B
Union, New Jersey 07083
(862) 955-9251
http://www.orielstat.com
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