Applied Quality Systems

Applied Quality Systems (AQS) is a consultancy firm focused on the establishment or improvement of quality systems for medical device product development, manufacturing, and/or distribution companies in Asia. AQS provides a wide range of services to assist new startup companies or existing companies in attaining successful Quality Management System (QMS) inspections/audits by international regulatory agencies. The range of services includes but not limited to design controls, gap assessments, root cause investigations for effective corrective/preventive actions, supplier improvement programs/qualifications, product/technology transfers, validations, risk analyses, quality audits, continuous improvements/preventive actions, preparation for US FDA/ISO 13485:2003/MDD inspections/audits, post market surveillance activities and GMP/QMS training. Clients will be working with a highly seasoned professional with over 15 years of direct Class II/III medical device industry experience in the US and Asia. AQS brings a successful track record in QMS inspections/audits by the US FDA for manufacturing site change of PMA products, EU Notified Body for ISO13485:2003 QMS/MDD certification, and Japan PMDA QMS inspection for accreditation of foreign medical device manufacturers to the client.