in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations... Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA...
and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Experience developing ways of accomplishing goals...
+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA...
quality, safety, health and environment systems continue to meet FDA, ISO, MDD, CMDCAS, EPA, OSHA and other appropriate...
/ MDD / CE, IEC 62304 / 62366, Design Controls / Design History File, Requirements Definition, Risk Management, Validation...
/ MDD / CE, IEC 62304 / 62366, Design Controls / Design History File, Requirements Definition, Risk Management, Validation...
, such as but not limited to FDA QSR ISO 13485, MDD etc. Knowledge of DBS Fundamentals, Danaher Material Systems and and Lean DBS tools...
medical device quality system regulations, including 21 CFR Part 820, MDD/MDR, ISO 13485:2016, and MDSAP. Working knowledge...
. Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable...
System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC...