80/20 Quality Consulting LLC

Quality assurance Consulting Services in the realms of Medical Devices, Biotech and Pharmaceuticals. Our mission is to provide exceptional quality services and help you meet your regulatory and internal business demands.

We have more than 16 years of diverse Quality Assurance and Quality Control experience in the implementation and maintenance of Quality Systems in accordance with US FDA QSR, MDSAP, ISO 13485, ISO 9001, 21 CFR 210 and 211, cmdr, and European pharmaceutical regulations.

Company’s Keywords:

software validation, mdsap, risk management, capa, supplier audits, mdr, internal audits, iso 9001, medical device single audit program, iso 14971, quality systems quality engineering, quality training, iso 13485