comprehensive of EU MDD 93/42/EEC, ISO 13485, MDSAP, ISO 14971, IEC 62366
lead auditor of ISO 9001, ISO 14001
extensive accreditation experiences subject to various Accreditation Bodies, e.g.German DAkkS, Taiwanese TAF and IECEE CB Scheme.
QMS Representative of international organization
Trainer of quality assurance, laboratory QMS, medical devices, product safety
internal auditor according to ISO 17025, ISO 17020, ISO 17021 and ISO 17065
Member of Taiwan national standards since 2003, Technical Committee Quality Assurance, sponsored by the Ministry of Economic Affairs / Bureau of Standard, Technology and Metrology
Specialties: comprehensive of EU Directives LVD, MSD, MDD, AIMD, Toys, Ne...
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