Course offering number:0809-404
Course ID:
2092
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
September 22-24, 2008
New Brunswick, NJ
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
- R&D
- QA
- 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.