Medical device training courses – available online or on-site at hotel. HRD Corp Claimable Course Scheme.
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
Others
- Intellectual Property Rights in the medical device industry
- Lean Six Sigma Foundations
- Lean Six Sigma Yellow Belt
- Lean Six Sigma Green Belt
- Lean Six Sigma Black Belt
- Lean Foundations
- Lean for Managers
- Lean Enterprise
- Lean for Manufacturing
- Cross Functional Process Mapping
- Process Control & Capability
- Applied Statistics
- Design for Six Sigma
- Design for Lean Six Sigma
- Level Pull & Kanban Design Workshop
- Total Productive Maintenance
- Achieving Results Through People
- Lean Assessment
- Value Stream Mapping
- Problem Solving Skills
- Business Process Improvement
- Lean Six Sigma Champions Workshop
- Lean Six Sigma Jumpstart Workshop