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Book
Orion Canada Inc. is pleased to announce the
latest (2017) publication of its reference guide prepared for
Global Affairs Canada, entitled:
Quality System Requirements
for Medical Devices: Reference Guide for Manufacturers
Selling Medical Devices in Europe, Canada and the United
States
Rapid changes continue to
reshape the regulatory framework for medical
devices as industry moves ever closer towards
global harmonization of quality systems for
medical devices.
Orion Canada, the recognized leader in this
field in Canada, was contracted by Global
Affairs Canada to write an update to Orion
Canada's popular "must have" reference guide for
medical device manufacturers.
The 2017 version addresses current requirements.
It is recommended reading for those new to
medical devices and and a practical source of
information for experienced practitioners.
The Orion Canada reference guide is not intended
to be a “how to implement” guide for a
particular standard. Rather, it should be viewed
as a road map to help medical device
manufacturers determine the quality standards
that apply to their products.
The Orion Canada reference guide identifies and
explains the quality requirements for the
European Union, Canada, and the United States as
expressed in the following:
• Europe’s Council Directives 93/42/EEC of 14
June 1993, concerning medical devices including
the revision 2007/47/EC and 98/79/EC of 27
October 1998, concerning in vitro diagnostic
medical devices; Commission Directives
2000/70/EC of 16 November 2000, concerning Human
Blood or Plasma; 2003/12/EC, 3 February 2003, on
the reclassification of breast implants and
2003/32/EC of 23 April 2003, with respect to
medical devices utilizing tissues of animal
origin.
• The Canadian Medical Devices Regulations (CMDRs)
• The United States’ FDA Quality System
Regulation (QSR)
The Orion Canada reference guide briefly
describes other features of these jurisdictions,
including device classification, registering a
quality system, selecting a registrar or
notified body, post-market surveillance and
problem reporting, labelling, EU representation,
and the Federal Drug Administration's (FDA)
premarket notification and premarket approval.
Useful information sources pertaining to each
jurisdiction are also provided in the reference
guide.
The updated Orion Canada reference guide has
been updated to include comments on the:
• International Medical Device Regulator’s Forum
(IMDRF)
• Medical Device Single Audit Program (MDSAP)
• Significant changes to each jurisdiction since
the 2010 version
• The Canada Europe Trade Agreement (CETA)
• The introduction of ISO 13484:2016 and ISO
9001:2015
• EU Medical Device Regulation (MDR) and In
Vitro Diagnostic Regulation (IVDR), and
• Digital Health Solutions.
If you would like a free e-copy of the 226 page
reference guide and/or assistance with your
compliance to regulations, you may contact Orion
Canada at
info@orioncanada.com.
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