QUALITY SYSTEM MANUAL - Exsurco
3.1.1 For the purposes of this document, the terms and definitions given in ISO 13485 and U.S. QSR (21 CFR 820) apply. 4.0 QUALITY MANAGEMENT SYSTEM 4.1 GENERAL 4.1.1 Exsurco Medical has established, documented, implemented and maintained a Quality Management System (QMS) in accordance with the requirements of ISO 13485 and U.S.QSR (21 CFR 820). ................
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