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Medical Device Training Courses

  • Cleanroom and Associate Controlled Environment
  • Design of Experiment
  • Effective Root Cause Analysis
  • EU Medical Device Regulations (EU MDR 2017/745)
  • Failure Modes, Effects and Criticality Analysis in Medical Device  Manufacturing (FMECA)
  • ISO 13485 : 2016  QMS
  • ISO 13485 : 2016 Internal Auditing
  • Labelling of Medical Devices (ISO 15223-1:2016) & Medical Device Classification
  • Malaysian Good Distribution Practice for Medical Devices (GDPMD)
  • Malaysian Good Distribution Practice for Medical Devices (GDPMD) Internal Audit
  • Medical Device Manufacturing Process Validation
  • Medical Device Design Control
  • Medical Device Single Audit Program (MDSAP)
  • NCR, CAPA & Complaint Handling
  • Risk Management for Medical Devices (EN ISO 14971:2019)
  • Software Validation Requirements and Excel Spreadsheet Validation
  • Test Method Validation
  • US FDA 21 CFR Part 820 – Quality System Regulation
  • Post Market Surveillance, Vigilance and Adverse Event Investigation
  • Pre-Market Notification 510k Submissions Workshop
  • Australia Therapeutic Goods (Medical Devices) Regulations
  • Sterilization (EtO)
  • Sterilization (Gamma)
  • US FDA Quality System Inspection Technique (QSIT)
  • CMDR and the Canadian Medical Devices Conformity Assessment System
  • Japan MHLW Ord 169
  • Developing Technical Documentation
  • Biological evaluations (ISO10993)
  • Clinical Investigations for Medical Technology

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