Regulatory Affairs

Orion Canada strives to make the complicated world of medical device regulations and standards less complicated by providing "one-stop shopping" for its clients. This one-stop shopping approach offers:

• Interpreting the relationship among various regulations and standards that impact on medical device companies importing or exporting to the US, Europe and elsewhere, including:

  - ISO 13485:2016 certification,

  - US FDA Quality System Regulation and all MDSAP jurisdictions,

  - UK MHRA,

  - CE Mark including the EU Medical Device Regulations, and

  - Health Canada CMDR and Medical Device Establishment Licence - MDEL applications

• European Union Medical Device Regulation - EU MDR – Regulation (EU) 2017/745

• Preparing the Design Dossier and Product Technical Files

• Selecting the Notified Body/Registrar

• Establishing Post-market surveillance

• Establishing a Vigilance/Mandatory Reporting system
  Device Licensing

• Establishment Licensing, including preparing for Health Canada MDEL inspections

• Device Classification

• Premarket Approval

• Premarket Notification - 510(K) submissions

• Providing Authorized Representatives in Europe and the US

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.