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HomeTraining Courses and SeminarsIndustry Specific TrainingMedical DevicesQuality ManagementISO 9001 - Medical Devices Auditor Transition Training
The Medical Devices Auditor Transition Training is designed to familiarize quality and regulatory professionals, engineers, supervisors and management with the quality system requirements under which medical devices are designed and manufactured.
The objective of this training is to inform delegates on the additional requirements of ISO 13485:2003 and their interpretation. The quality system of requirements of EC directives 93/42/EEC (medical devices) and 98/79/EC (in vitro diagnostic medical devices) are also included to allow full understanding of quality systems required to achieve CE marking.
Upon completion of this training delegates will be able to:
Delegates are expected to have a working knowledge ISO 9001:2008 Quality Management principles. It is also advisable to have also read the standard ISO 13485:2003.
Contact SGS today to find out more about SGS ISO 9001 to Medical Devices Auditor Transition Training.