Our Director/ Principal Consultant

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

She provides consulting, training services and product solutions to the medical device and related industries for regulations in jurisdictions such as Singapore HSA, Malaysia MDA, US FDA, EU etc. Principle areas of expertise include:

  • 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 SS620:2016 Singapore Standard – Good Distribution Practice for Medical Devices – Requirements, MDA/RR No.1 Good Distribution Practice for Medical Devices (GDPMD), 21 CFR Part 820 and ISO 13485
  • Support companies with respect to regulatory Inspections & necessary preparations e.g. US FDA and MDSAP
  • 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, , Singapore etc

She is also a member of Working Group 6 (WG6) – Quality Management System: Audit & Assessment – of the AHWP (Asian Harmonization Working Party). 

 

 

   
OUR PARTNER
  • MD-CLINICALS Europe

    Route de Denges 28C
    1027 Lonay
    Switzerland

    Phone: +41 21 349 96 36
    Mobile: +65 98656730
    Fax: +41 21 349 96 37
    Site: www.md-clinicals.com
Call us at 6659 0979
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