In house training courses for medical device manufacturers
If you have 3 or more staff to train, an in house course may be more cost effective.
- Intro to Medical Devices - the quality and regulatory framework
- CE Marking - An introduction to 93/42/EEC The Medical Device Directive
- CE Marking - An introduction to 98/79/EC In Vitro Diagnostic Medical Devices Directive
- Understanding ISO 13485:2003 Medical Devices - Quality Management System - requirements for regulatory purposes
- Expand your markets - USA regulatory compliance - 2 days
- Expand your markets - Australian regulatory compliance
- Expand your markets - Canadian regulatory compliance
- Creating a Technical File/Design Dossier in STED Format
- Risk management of Medical Devices ISO 14971 - 2 days
- Biological Evaluation of Medical Devices ISO 10993-1 changes incorporating risk management - 2 days
- ISO 13485 Internal Auditor - 2 days
- Quality System Inspection Technique (QSIT)
- Preparing for regulatory audits
- Introduction to Microbiology
- Sterilisation - Ethylene Oxide
- Sterilisation - Gamma & Electron Beam
- Sterilisation - Steam
- Contamination Control
- Cleanroom GMP
All courses are tailored to meet the customers unique training profile.
