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MEDICAL
DEVICE QUALITY SYSTEMS MANUAL...
530 pages of compliance quality initiatives for all
companies operating under US GMP requirements...
...covers the
Quality System regulation and the basic Good
Manufacturing Practices (GMP) requirements that all
manufacturers and distributors must consider when they
plan to manufacture medical devices, including medical
device kits, trays or packs, for distribution in the
United States. Model procedures and sample forms are
also included in the manual to assist manufacturers.
Adherence to the medical
device Quality System regulation makes good business
sense and also serves public health aims -- two very
good reasons for the Food and Drug Administration (FDA)
to encourage compliance. However, a prerequisite to
complying with a regulation is a clear understanding of
its content.
Covers:
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