Bruno José Silva de Oliveira

IRCA Certified lead auditor for ISO 13485:2016, by BSI Masters of Materials Science and Engineering at Federal University of São Carlos. Bachelors of Materials Engineering at Federal University of São Carlos. Seven years of experience in regulated work environments, part in mechanical/chemical testing laboratories, part in medical devices manufacturers/importers/distributors (non-active invasive and active non-invasive) dealing with national and international regulatory affairs, quality management systems and certification of medical devices. Work experience comprises national and international regulatory submissions and revisions, product certification, mechanical and materials testing, design controls, risk management, quality assurance, quality systems, post-market surveillance of medical devices, handling of customer complaints and diverse normative systems.