Medical Devices

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 in: 

• 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 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

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 nonconformity.

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 requirements.

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 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.