Ms. Tan Hwee Ee is the Founder of DH RegSys in Singapore and Co-Founder of MD-CLINICALS Malaysia, a clinical research organization which manages 100% medical devices. She has 20 years of experience in the medical industry principally in medical device organizations as a consultant, engineer and senior manager.
She provides consulting and training services and product solutions to the medical device and related industries for regulatory bodies such as Singapore HSA, Malaysia MDA, Australia TGA, US FDA, EU and etc. Principle areas of expertise include:
- Consulting advice in developing programs and operating procedures to ensure compliance to regulatory requirements like 21 CFR Part 820, ISO 13485, Singapore’s TS-01 GDPMDS (Good Distribution Practice for Medical Devices) and Malaysia’s MDA-RR No 1 – July 2013 GDPMD (Good Distribution Practice for Medical Devices).
- External trainer engaged by SGS International Certification Services Singapore Pte Ltd
- Subject Matter Expert at the World Medical Device Organization
- Consulting advise in developing programs and operating procedures to ensure compliance to regulatory requirements like 21 CFR Part 820 and ISO 13485
- 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, Singapore etc.
- Subject Matter Expect (SME) for WMDO (World Medical Device Organisation)
- Member of Working Group 6 (WG6) of the AHWP (Asian Harmonization Working Party).