SME Profile

Hwee Ee Tan

Hwee Ee has 20 years of experience in the medical industry principally in medical device organisations 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, Australia TGA, US FDA, EU and etc. Principle areas of expertise include:

  • External trainer engaged by SGS International Certification Services Singapore Pte Ltd
  • 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

She is also a member of Working Group 4 (WG4) of the AHWP (Asian Harmonization Working Party).