Southern California LNG In Person Event: Medical Device Symposium & Workshop Sponsored by SGS

Simon Choi

Senior Policy Advisor , Division of Standards and Conformity Assessment (DSCA) at the Food and Drug Administration

Simon Choi is a Senior Policy Advisor with the Division of Standards and Conformity Assessment (DSCA) at the Food and Drug Administration. He has led major public health projects and initiatives at FDA for medical imaging, directed CT medical imaging safety investigations and developed regulatory policies for Digital Health. Previously, Dr. Choi was Director of the Master of Public Health program at the University of Kansas Medical Center and served as Assistant Professor in the Department of Preventive Medicine.

Leo Pidone

Technical Reviewer / Lead Auditor, Medical Devices, SGS

Leo Pidone started his professional journey over 30 years ago. He built a strong foundation in physics, medical physics, testing, certification, quality management, and regulatory assessment. His career includes work in medical device laboratories, certification bodies, notified body operations, technical documentation assessment, management systems auditing, and leading international teams in Brazil, Germany, and the United States.

Leo currently works at SGS North America as a Technical Reviewer, Certification Decision Maker, Technical Documentation Assessor, Product Assessor, and Lead Auditor for medical devices. In this role, he supports certification and regulatory activities for MDR, MDD, AIMDD, ISO 13485, MDSAP, and other medical device requirements. His work involves reviewing technical files, making certification decisions, managing complaints and qualifications, and conducting conformity assessments for active, active implantable, software, and non-active medical devices.

Earlier in his career, Leo held senior technical and leadership positions at TÜV SÜD in the United States and Germany. He worked as a Technical Certifier, Technical Documentation Assessor, Lead Auditor, and Expertise Manager for audit operations, onboarding, and training. His experience includes making notified body certification decisions, assessing MDR/MDD technical documentation, reviewing MDSAP submissions, auditing ISO 13485, and assessing medical devices, with a special focus on patient monitoring devices, including both life-supporting and non-life-supporting technologies.

Leo's technical background comes from laboratory testing, medical device safety, IEC 60601-series standards, ISO 17025, GLP, validating sterile medical product packaging, transport simulation, supporting risk analysis, and certification processes under international regulations. He has also led initiatives to improve operations, trained auditors and technical staff, managed multinational teams, and supported changes that reduced training time, improved authorization controls, and strengthened certification operations.

For this RAPS workshop, Leo offers a practical perspective focused on how manufacturers can create risk management files, develop labeling and IFU outputs, establish clinical evaluation linkages, provide PMS/PMCF rationale, and ensure GSPR traceability within a cohesive MDR/UKCA compliance story. His approach blends technical knowledge, audit discipline, regulatory common sense, and clear communication. He helps manufacturers understand what reviewers expect and how to prepare documentation that is consistent, defensible, and ready for review.

Balasz Bosnik

Technical Director medical audit team, SGS North America

With a passion for continuous improvement, Mr. Balazs Bozsik is the Technical Director for the medical audit team of SGS North America. Following his graduation as integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive, and consumer lighting industries. Prior to joining SGS, he worked for another TIC organization for over 14 years, including his roles as global MDSAP Program Manager, certification officer, product specialist focusing on active medical devices and medical software, as well as medical auditor for all major certification schemes.