Is risk management necessary? According to the EU regulations for medical devices (MDR) and in vitro diagnostics (IVDR), as well as the FDA design controls (USA), risk management is a mandatory requirement for manufacturers of medical devices.

The risk management process and the application of risk management to medical devices are described in the harmonized standard EN ISO 14971:2019+A11:2021.

The risk management process extends throughout the entire product lifecycle of a medical device, across all areas of the company, up to the end user, and ideally begins even before product development.

Our portfolio also includes software risk management (EN 62304), usability (EN 62366), and risk management for ME equipment (EN 60601-1), as well as the integration of these requirements into product development and the approval process.

Our offer

  1. We meet you where your risk management currently stands.
    To do this, we analyze your existing processes and your risk management file in a process audit. The result is an audit report. All further steps are carried out using your sample product.
  2. In a basic workshop, we develop a risk management process tailored to your needs and, together, create all necessary templates for your sample product, such as the risk management plan or a tabular risk analysis, etc.
  3. In a brainstorming session, we jointly identify and assess the risks and define measures for risk mitigation. This way, we coach you through the entire risk management process.
  4. The result is an optimally tailored risk management process and a risk management file illustrated with your own examples, as well as proof of competence through training as a risk manager.

Interested? We would be happy to advise you!

Our current combined offer: Consulting & Seminar ISO 14971 – Risk Management for Medical Devices:

Register now for one of our upcoming ISO 14971 seminars. Book our “Risk Management” consulting package at a special price for seminar participants at the same time:

  • Reviewyour risk management file
  • ½ day process audit: risk management on site
  • Audit report: The risk management process, including document templates, source directories, links, and checklists.
  • ½ Tag „HandsOn“ Risikomanagement-Workshop for your product.
  • 3 month “Fair Use” Follow up-Hotline.

Our upcoming seminars for ISO 14971 you can find here.

Contact us: office@encotec.at or +43 1 8863491.