The Center for Professional Advancement, Isla Verde, Puerto Rico
March 31-April 2, 2008
Who Should Attend
Participants who work in the medical device industry and who currently are or wish to sell their product in the US, Europe and other parts of the world will profit by attending this course. This includes professionals responsible for understanding and interpreting global regulations within their companies, in areas such as:- Regulatory
- QA
- R&D
- Manufacturing
Description
This course provides a detailed description of the current European and US regulations for medical devices. With the continued growth in the development and acceptance of global standards, all device companies must stay up to date on the various regulations to ensure marketability of their products globally. With 25 European countries now using the ISO 13485 standard, it is critical to companies to understand how the similarities and differences in these standards can be implemented into their own quality system to enhance their marketability. The primary focus of this course is on the development of one quality system which complies with the ISO 13485:2003 standard, ISO 9001:2000 standard and the FDA Quality System Regulations. Participant interaction, problem solving and open discussion will be strongly encouraged.
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