Tetsuya Miyata

Background

About Tetsuya Miyata

Business Development Leader in Medical Device Testing and Compliance With cross-functional experience across the medical device and pharmaceutical industries, I support manufacturers in navigating global compliance landscapes. My role involves guiding clients through testing, certification, and regulatory alignment — covering both active and non-active medical technologies. My expertise includes: • Biological safety evaluations (ISO 10993 series, preclinical studies) • Electrical safety and performance testing (IEC 60601 series) • Software lifecycle and cybersecurity risk management (IEC 62304, ISO/IEC 27001, IEC 81001-5-1) • EU MDR/IVDR alignment and documentation readiness • Global regulatory knowledge (FDA: 510(k), PMA, De Novo) • Clinical evaluation and post-market requirements (CEP/CER, PMCF; informed by GCP) • Cleaning and sterilization validation (for reusable/reprocessed devices) • Quality and risk-based systems (ISO 13485, ISO 14971) I completed GCP training with the U.S. NIDA, covering IRB roles, subject safety, consent, QA, and documentation. This background bridges regulatory expectations and practical documentation. Through collaboration with labs, RA teams, and NBs, I connect innovation with compliance to meet real-world patient and healthcare needs. ISO 10993 IEC 60601 IEC 62304ISO/IEC 27001IEC 81001-5-1 MDR/IVDR FDA510(k)PMADe Novo CEP/CERPMCFGCP ISO 1348514971 NIDAGCP IRB NB