Sew-Wah Tay Email & Phone Number

I have been part of a team that helped bring many safe and effective medical products to the market that benefit patients. I enjoy the challenge of helping guide new and innovative technology through the regulatory and clinical process to market in the shortest time possible.Working in a small company environment with less resources and less historical information is the type of challenge that I and my colleagues at Libra Medical thrive on. Check us out at www.libramed.comClinical: We can assist in designing and running GCP and postmarket Clinical Trials. We have developed protocols, CRFs, monitoring plans, data management plans, CEC and DMC charters. We work with you to conduct the clinical studies from start to finish.RegulatoryExperienced in getting approvals in major markets around the world including US (PMA, IDE, 510(k)), EU (Design Dossier, Technical File), Canada, and Australia. Quality Systems ManagementHave developed first class quality systems that facilitates creativity and acceleration of time lines rather than slowing the process down. Internal audits, supplier audits, and 3rd party audits.Risk Management and Human FactorsConduct ISO 14971 compliant risk management activities. Plan and conduct human factor studiesManagementHave successfully managed, developed and grew three sets of teams in Regulatory, Clinical, and Quality. Have worked as a management consultant in these area and steer the department(s) to success.Specialties: Provide an integrated approach to Regulatory, Clinical and Quality so the three departments work together synergistically for faster path to market.