Orion Canada Inc.
Orion Canada Inc.  
      Consulting Auditing Outsourcing


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.