Orion Canada consultants
are fully certified ISO 13485:2003, CE Mark
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
- ISO 13485:2003 Medical Devices - QMS Requirements
- FDA Quality System Regulation
- Canadian Medical Devices Regulations including CMDCAS
- Preparing for Medical Devices
Establishment Licence (MDEL) Inspections
- Europe’s Council Directive 93/42/EEC of 14 June
1993 and the
2007/47/EC amendments, concerning Medical Devices - Medical
Devices Directive (MDD) including CE Marking
- The 2007/47/EC amendments to the EC
Medical Devices Directive
- ISO 14971:2007 Application of Risk Management to
- Other supporting medical device and quality system
requirements and guidelines including MEDDEV, GHTF
and ISO standards, including ISO 62304
Medical Device Software - Software Life-cycle
Compliance with the new medical device CE Marking
requirements due by March 2010
Europe’s Medical Devices
Directive (Council Directive 93/42/EC, of 14
June 1993 Concerning Medical Devices) is being
modified and the changes will come into full
force on March 21, 2010. If not compliant by
that time registrars will issue a major
Registrars have already begun issuing nonconformities to manufactures who have not
shown an action plan to
bring their MDD up-to-date with these new
Orion Canada has assisted many organizations in becoming fully
compliant with the 2007/47/EC amendments to the
Medical Devices Directive.
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
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
FitzGibbon for more information on how Orion Canada
can assist your organization.