How I can help you
I can assist you in complying with the food and drug regulations and FD&C Act covering medical devices that are marketed and distributed within the United States. I have over 39 years of experience in auditing quality management systems (includes applicable procedures, applicable documentation), medical device labeling, promotional/advertisement labeling, 510(k) and Premarket submissions, clinical studies, imported medical devices, reviewing establishment registrations and medical device listings. I achieved and maintained medical device level II and medical device auditor (more than 15 years); and worked directly with the State Food and Drug Branch (Medical device Section). I maintained a supervisor position reviewing completed work products (foods, pharmaceuticals, bioresearch monitoring) and program management (medical devices) where I reviewed completed work products of Consumer Safety Officers (Investigators); determined the yearly medical device establishment workplans; made presentations to industry organizations; and for 5 years, taught business courses at a local community college.
Areas of Expertise
- Government Regulations & Contracting
- Product Development & Manufacturing
- Educational Services
- Professional, Scientific, & Technical Services