Orion Canada Inc.
Orion Canada Inc.  
      Consulting Auditing Outsourcing

Medical Devices

Orion Canada consultants are fully certified ISO 13485, 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 in: 

  • ISO 13485 Medical Devices - QMS Requirements
  • FDA Quality System Regulation and other relevant CFR title 21 parts
  • Canadian Medical Devices Regulations including CMDCAS
  • Preparing for Medical Devices Establishment Licence (MDEL) Inspections
  • Europe’s CE Marking requirements, Council Directive 93/42/EEC of 14 June 1993, concerning medical devices, including the 2007/47/EC amendments (Medical Devices Directive - MDD)
  • Europe's CE Marking requirement, Council Directive 90/385/EEC of 20 June 1990, concerning active implantable medical devices (AIMDD)
  • Europe's CE Marking requirement, Council Directive 98/79/EC of 27 October 1998, concerning in vitro diagnostic medical devices (IVDD)
  • Preparation of the CE Marking and Technical File
  • Preparing the Design Dossier
  • ISO 14971:2007 / EN ISO 14971:2012 Application of Risk Management to Medical Devices
  • 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 Processes

Upcoming changes to the Council Directive 93/42/EEC of 14 June 1993

In response to the European Parliament Resolution of June 2012, proposed changes to MDD are being discussed with various Competent Authorities and EU Commission representatives and a final version will likely be published in late 2016. Orion Canada is following these developments closely and will be in a position to offer training on the final version as well as assisting in the transitioning to this version once a final copy is published. Orion Canada will also will also follow progress on proposals to strengthen the IVDD and will be in a position to assist clients in adapting to these changes when these are finalized.

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.

Quality Management
Environmental Management
Info Security Management
Medical Devices
Regulatory Affairs