Pavithra is a Quality Specialist who has knowledge and expertise in device regulations and itsapplications such as FDA QSR, International Standards including ISO 13485:2003 and MedicalDevices Directive (MDD). Pavithra is currently ASQ Six Sigma Yellow Belt certified and holds aMasters of Engineering (M.Eng) degree in Biomedical Engineering from the University ofVirginia. In her Masters Project, Pavithra focused on the discovery and development of a novelsurgical scalpel tool integrated with spectrometric features to aid surgeons in performingParotidectomy surgery.As a Quality assurance specialist, Pavithra has a true passion for the the design anddevelopment support of products, facilitating the application of design/change controls, riskmanagement, quality plan, and implementation of design and development plan. She alsoprovides QA support for internal Quality Systems growth. Her expertise lies primarily inImplementation and maintenance of quality systems, policies, and procedures that ensurecompliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part806, 21 CFR part 20) and other applicable standards.