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ZELI ( Scott ) YU , RAC Global

ZELI ( Scott ) YU , RAC Global

Notified Body Auditor

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  • Timeline

  • About me

    Chief Medical Device Consultant -YUZELI MEDTEC CONSULTANT INC.

  • Education

    • Shanghai Jiao Tong University

      1988 - 1993
      BS Meidcal Technologist

  • Experience

    • TUV SUD China

      Jan 1998 - Jan 2003
      Notified Body Auditor

    • British Standard Institute

      Nov 2003 - Dec 2009
      Healthcare Product Manager

      Notified Body Audit per ISO 13485， MDD / IVDD FDA mock inspection per QSIT 21 CFR 820 and MDD training

    • Scott Ownership Consultation

      Jan 2010 - now
      Medical Device Consultant

      FDA, CE , Chinese Device GMP consultation

    • Johnson & Jonson

      Jan 2010 - now
      Contract Supplier Auditor

    • YUZELI MEDTECCONSULTING

      Jun 2017 - now
      Medical Device Regulatory Consultant

      Medical Device regualtion consulting in the field of Chinese device GMP, CFDI oversea inspection , US FDA , CE mark , WHO , Brazil Registration etc. Healthcare laboratory regulation consulting ; ISO 15189 & CAP

  • Licenses & Certifications