Quality Management System (QMS)
Compliance:
Regulatory Progress Associates
(RPA) has extensive experience with
US, Canada and international
regulations, so we can perform an
audit on your behalf to determine
your firm's level of compliance with
all applicable requirements. As part
of that process, we will evaluate
the company's Quality Manual and
Standard Operating Procedures to
ensure that applicable regulatory
elements are being followed in
regions where products are marketed.
• ISO 13485:2003 - Review of QMS to
ensure compliance. RPA will also
ensure that additional QMS
requirements imposed by Canada,
Europe and others like Australia is
maintained.
• US Quality System Regulation - RPA
will review compliance with 21 CFR
Part 820 and will identify potential
areas of concern if the FDA were to
conduct an on-site inspection of
your firm
Call us
or email us your questions. We'll
get back with a free estimate.
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