disorders (major depressive disorder, MDD) and schizophrenia. Of particular research interest to the program are issues related... to suicidal ideation and behavior and impulsivity, as well as treatment resistant depression and device-based treatments for MDD...
implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR/MDR requirements. Supports the creation...
Systems Understanding of additional regulations and standards: ISO 14971, MDD, MHLW, SOR/98-282, Therapeutic Goods...
quality engineering or related engineering discipline. Experience with quality management systems in FDA, ISO 13485, and MDD...
System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC...
Systems Understanding of additional regulations and standards: ISO 14971, MDD, MHLW, SOR/98-282, Therapeutic Goods...
quality engineering or related engineering discipline. Experience with quality management systems in FDA, ISO 13485, and MDD...
; Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred; Minimum of three years...
and update quality system procedure to achieve continuous compliance to ISO13485, European MDD/MDR, and MDSAP. Assist in the.... Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223...
, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements. Strict attention...