Regulatory Essentials for Medical Devices

Yeoh Wei Yee, business manager, UL Solutions

Yeoh Wei Yee is a medical business manager at UL Solutions, leading medical device testing and certification initiatives across the Association of Southeast Asian Nations (ASEAN), Australia and New Zealand. He oversees market strategy, laboratory capability development and operational execution to support manufacturers in meeting global regulatory and safety requirements. With expertise spanning across IEC 61010-1, IEC 60601-1, and its collateral and particular standards, Wei Yee partners with industry stakeholders to deliver high-quality, audit-ready compliance outcomes that accelerate product launch and market access.

Sreenu Sattu, manager, Quality and Regulatory Affairs program, Emergo by UL

Sreenu Sattu has nearly 20 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic devices (IVD), covering products of all risk classifications. Sreenu’s background includes establishing regulatory strategies for registrations, integration activities, compiling EU technical files, common submission dossier templates (CSDT) for submissions in the Asia-Pacific (APAC) region, U.S. Food and Drug Association (FDA) 510ks, and Therapeutic Goods Administration (TGA) submissions, including clinical evaluation reports and post-market surveillance. He also has experience in ISO 13485 audits, gap assessments and FDA Quality System Inspection Technique (QSIT) inspections.

In his current role, Sreenu manages the regulatory and quality compliance needs of Emergo’s APAC and international clients. Prior to joining Emergo by UL, he held regional and leadership positions at Life Technologies (now part of Thermo Fisher Scientific), Vela Diagnostics, Cardinal Health and Abbott.