Regulation
There are a
range of regulations that medical device
designers, specification developers,
manufacturers, re-labellers, sub-contractors
and distributors must comply.
Specifically
at this stage our courses focus on EC and US
requirements and we have developed specific courses
that are designed to provide an appreciation
and understanding of the key regulatory
requirements and how they can be addressed in
the organisation. As appropriate courses have
been developed at two levels:
-
One-Day Workshop:
Introductory Level designed for delegates who wish an appreciation
of the requirements and the key aspects of the regulation.
-
Two-Day Course:
Designed for delegates who wish to design, implement and improve
systems that will evidence compliance with the regulation.
Currently
these Workshops and Courses are company
specific and are designed to be held with a
minimum of five delegates.
Each Course
and Workshop is designed to meet defined and
agreed outputs and are conducted in a manner
that engages our delegates.
Delivered by both expert and
experienced Regulatory Affairs consultants /
trainers each workshop and course is supported
by a complete manual containing a copy of
presentation slides and reference materials.
Call
Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk
to discuss your needs.
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MEDICAL DEVICE DIRECTIVE |
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Designed to
provide awareness and /or training in EC regulation governing
the classification of devices, compliance routes, essential
requirements and post market surveillance.
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CFR 820 QS REGULATION |
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Designed to
provide awareness and/or training in the FDA Quality System
Regulation.
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