Irwan shah M.
Biomedical / Mechanical Assistant Product Development Manager
I have about 10 years research and development experience in wide range of medical device products inclusive of intravenous / arterial / butterfly needles, several types of catheters (pulmonary artery, central venous catheters, intravenous), gastrointestinal implant products, vascular stents, administration sets (tubing, spikes, contrast saver setting), guide-wire and stopcock valves within research universities and manufacturing environment.
My core competency would be in project management and mechanical medical device product design inclusive Class II and III devices. I have successfully handled 15 major projects from conceptual to regulatory submission (FDA, CE, MHLW and CFDA) which inclusive design freeze, design for manufacturing, process verification and validation, design verification (bench test), preclinical animal study (hands-on implantation experience), clinical study and regulatory documentation preparation / submission.