International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
, MDD / IVDD / IVDR / MDR/ ISO14971 Strong background in root cause analysis, Risk Management, FMEA, Health Hazard...
or biopharmaceutical environment. Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
develop comprehensive regulatory strategies relating to PMA, IDE, ''510(k) premarket notifications, EU MDD Technical File/MDR...
. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...
and External Audits as required. Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations...
. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...
-1:9, our unit treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia...
regulations, ISO13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished...
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology Optical...