With a unique
expertise in quality assurance and
regulatory affairs, Cofactor
Technologies offers an attractive
combination of both computer systems
and medical device quality assurance
development to companies of all
sizes.
Our company has
the expertise to support and
implement quality systems compliant
with FDA’s 21 CFR 820, Europe’s Medical
Device
Directive,
Japan’s PAL
Ministerial Ordinance 169,
Canada’s Medical
Devices Conformance Assessment
System (CMDCAS),
and the internationally recognized
ISO 13485 regulations. We can work
with your company to cater the most
appropriate quality system and
method for your business and your
market desires. We can also
provide assistance with a wide
variety of regulatory submissions
and device licenses to improve time
to market for
products in the United
States, Canada, Japan, Europe,
Korea, and China.
For non-medical
applications, our company has the
expertise in Microsoft server
administration, website development
and networking systems to improve
your company’s productivity and
growth potential. We offer a
range of services from creating a
new website, modifying an existing
website, designing and installing a
new server / network layout, or
modifying an existing server /
network setup.
