Regulatory Evaluation of
Changes
(For US FDA and Health
Canada)
All changes to medical
devices MUST be
evaluated for their
regulatory impact.
Cleared (510k) and
Approved (PMA) as well
as devices that hold
Canadian Medical Device
Licenses - require
special attention in
reviewing, approving and
recording the decision
to submit for new
application or not.
This extensive procedure
provides you with all
the tools - right down
to the "considered memo"
you will need to
generate to maintain in
your files as proof that
your organization
adequately reviewed all
changes to your medical
device.
All our procedures are
easy to modify so
that you preserve the
look and feel of your
own quality system
documentation.
File type:
Procedure
Format: Microsoft Word
Price for download:
$ 59.00 USD
