Medical
Device Standard ISO 13485: 2003 Interpretation,
Implementation & Transition
This class is designed for Medical Device companies planning to update to the new ISO 13485:2003 standard. The course is intended to provide a background and familiarity with the purpose, requirements, and application of the full variety of Medical Device Regulations, Standards, and compliance issues that face Medical Device Organizations. It will provide and outline of the requirements, interpretation and key differences with FDA, QSR and the 1996 version of ISO 13485. The course will also demonstrate how ISO 13485:2003 will interact with the ISO 9001:2000 Standard and the requirements of European and Canadian Medical Device regulations. Also covered are: documenting your management system for compliance and efficiency; addressing multiple regulations, process auditing and tips for surviving a compliance inspection. Ideal for manufacturing managers, regulatory staff or anyone operating in a compliance environment.
The course includes the following segments
Course Fee $750.