Medical Device Quality Systems: How to Comply with Global Regulations
March 26 - 27, 2012
Amsterdam, The Netherlands
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This course is available as a client site course. Please click here for more information.
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 quality system requirements 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. The primary focus of
this course is on the description of one quality system which
complies with the ISO 13485 standard and the FDA Quality
System Regulations and the documentation needed to
support them.
Participant interaction, problem solving and open discussion
will be strongly encouraged.