Eva Min

Lead ISO 13485:2016‑compliant Quality Management System (QMS) activities, including documentation, CAPA, internal and external audits, and training Support and coordinate FDA IDE and De Novo submissions for robotic‑assisted surgical systems Led CE MDR submissions (BSI) for robotic‑assisted endoscopic surgery systems (Class IIb), hardware instruments (Class IIa), and consumable instruments (Class Is) Develop and maintain risk management and usability engineering documentation in accordance with ISO 14971 and IEC 62366‑1 Manage third‑party validation activities, including ISO 10993 biocompatibility testing, packaging and sterilization validation, and reprocessing (cleaning and sterilization) validation Serve as the primary RA/QA point of contact for cross‑functional teams and executive leadership

Established and maintained an ISO 13485‑compliant QMS from early‑stage development, achieving initial certification and surveillance audits (BSI) Led FDA 510(k) and IDE submissions for Class II surgical robotic systems Prepared technical documentation and validation for reusable robotic surgical instruments and single‑use accessories Led CE MDR submissions (BSI) for Class IIb robotic systems and related Class IIa and Class Is instruments Performed biological and use‑related risk analyses and led usability engineering activities, including authoring HFE protocols Managed third‑party validation for biocompatibility, packaging, sterilization, and reprocessing

Provided MFDS licensing support for medical device importers and managed outsourced quality management activities Led import license amendments for Class IV absorbable sutures and Class II non‑implantable vascular access devices Prepared documentation for KGMP overseas manufacturer surveillance audits

Led MFDS Class II–IV (STED‑based) import registrations, including sutures (Class III & IV) and pre‑filled syringes (Class II) Served as Quality Management Representative and supported GMP inspections, including on‑site audits in China, achieving GMP certification for Class IV absorbable sutures Registered sutures as reimbursable medical materials with HIRA Managed and trained RA team members and facilitated communication between Chinese staff and Korean executives Managed domestic distributors

Served as RA lead for imported medical devices from the USA, UK, Canada, and China, completing 50+ MFDS (KFDA) Class II–IV registrations and amendments Managed outsourced testing and inspection plans and led MFDS re‑evaluation license amendments (2012) Served as Quality Management Representative and prepared overseas manufacturer audits Managed adverse event reporting, recalls, and regulatory communications

Provided RA and QMS consulting for medical device manufacturers and importers Handled MFDS Class I–IV registrations covering implants, consumables, and surgical instruments Coordinated product testing activities and overseas manufacturer communications