Companies that
manufacture medical devices may sometimes want to obtain a CE Mark for their devices allowing easier export and sales to Europe. These companies may need help in understanding the
required FDA regulations, as well as the Medial Device
Directives and associated standards. Q2
Consultants, Inc. provides contracted consulting services for
such companies. Q2 Consultants, Inc. has a team
of experienced consultants who can explain, train and implement
the requirements for CE Mark obtainment and the
documentation and implementation of the Medical Device Directives,
as well as provide value added service to the organizations
they consult.
The
President of
Q2
Consultants, Inc. has had experience as a Lead Auditor
in verifying compliance to the required standards of the CE
Mark process and has helped implement these standards
with multiple companies. Q2 Consultants, Inc.
can help
explain the
requirements,
generate the
required
documents, obtain the necessary applications and assist
in the implementation of systems to attain registration and
the CE Mark for the device. |
