HweeEe Tan

Principal Consultant/Founder, DH RegSys in Singapore/Australia and Consultant of MD-CLINICALS (a medical devices CRO).

Hwee Ee has more than 30 years of experience in the medical industry principally in medical device organizations asa consultant, engineer and senior manager.

She provides consulting and training services and product solutions to the medical device and related industriesfor regulatory bodies such as Singapore HSA, Malaysia MDA, Australia TGA, US FDA, EU and etc. Principleareas of expertise include:

• External trainer engaged by SGS International Certification Services Singapore Pte Ltd
• Subject Matter Expert at the World Medical Device Organization
• Consulting advice in developing programs and operating procedures to ensure compliance to regulatoryrequirements like 21 CFR Part 820 and ISO 13485
• Support USA FDA Inspections & necessary preparations
• Compliance to Good Manufacturing Practice (GMPs)
• Company Audits and Gap Analysis
• Industry Training and Seminars in Quality Assurance (QA) and Quality Management Systems
• Quality Manuals and supporting documentation
• Project Management
• Product development and Regulatory submissions in various countries including EU, USA, China, Singaporeetc

She is also a member of Working Group 7 (WG7) – Quality Management System –  of the GHWP (Global  Harmonization Working Party).