Medical Devices
Orion Canada consultants
are fully certified ISO 13485, CE Mark,
MDSAP
and CMDCAS lead auditors. When regulatory compliance
is essential, don't settle for anything less!
Orion Canada is the Canadian
leader in the design and development of quality management
and regulatory affairs management systems for the medical
device industry. Its
consultants are certified Lead Auditors for medical devices.
More than 200 medical device organizations have relied on
the Orion Canada approach to comply with medical device
standards and regulations.
Quality systems designed by Orion
Canada for its clients have been thoroughly scrutinized
hundreds of times through audits and assessments to the
highest industry standards. Consistently and without
exception Orion Canada designed quality systems have
passed every audit, test and evaluation.
Orion Canada clients benefit from the
unequalled experience, a proven methodology, and a track
record of delivering results that is second to none.
As a client of Orion Canada, you have the security of
knowing that you will succeed.
Orion Canada has an expertise
in:
Orion Canada has assisted many organizations in
becoming fully compliant with medical device
regulations.
Contact Orion Canada
to assist you in this process.
Free Reference Guide
Orion Canada Inc. is pleased to offer
its free reference guide on medical device quality system
requirements, entitled:
Quality System Requirements for Medical
Devices: Reference Guide for Manufacturers Selling
Medical Devices in Europe, Canada and the United States
This guide details the quality system requirements of the
three jurisdictions and identifies those requirements that
are common to each jurisdiction. This guide is intended
to assist medical device manufacturers in designing their
quality system to meet the requirements of one or more
of these jurisdictions. Get your copy today and let Orion
Canada Inc. assist your organization comply with the
new medical device requirements. Contact
Chris
FitzGibbon for more information on how Orion Canada
can assist your organization.
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