Risk Management for Medical Devices

*1 Place Remains*

  • Starts 12 Jul
  • 895 British pounds
  • Online Virtual Classroom

Service Description

13485:2016 requires medical device manufactures to implement a Quality Management System that has a greater emphasis on risk. Our industry leading experts have created this 2-day course on Risk Management for Medical Devices to help medical device manufactures meet this more rigorous focus on risk management. ​ Our tutors will provide you with an in-depth understanding of ISO 14971:2019 in addition to comparing ISO 14971:2019 with the requirements of the EU Medical Device Regulation (MDR) 2017/745.  ​ This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.  Course Agenda ​ Module 1 - Purpose, History and Structure of ISO 14971 - Key Changes introduced by ISO 14971:2019 - Definitions and Key Terminology - Relationship with other Standards - Risk Management and the Product Lifecycle ​ Module 2 - The Risk Management Process - The Risk Management Team and Roles  - The Risk Management Plan and What It Contains - The Risk Management File ​ Module 3 - Risk Analysis  - Hazards and Hazardous Situations - Risk Estimation, Probability. Severity and Detectability - Risk Evaluation Module 4 - Risk Control - Risk Analysis and Measures - Residual Risk and Risk Review​ - Benefit Risk Analysis - Production and Post-Production Activities - Implementation of Risk Controls - Risk Management Tools and Techniques  - AFAP and ALARP Module 5 - Overall Residual Risk Evaluation - Risk Management Review - EN ISO 14971:2012 vs EN ISO 14971:2019  - Purpose and Structure of ISO/TR 24971 - Annex Z Deviations - Overview of Key Annexes What you will receive: - 2 days of live online training - Browser-based, no downloads required - See presenters and interact with fellow attendees - Get your questions answered! - Download documentation and certification of completion What you need: - Internet access with Google Chrome - Access to a microphone (Webcam not required) Discounts are available for 3+ attendees. Please email us at info@meddevsolutions.co.uk for your unique discount code to use at the checkout.

Upcoming Sessions

Cancellation Policy

Places are non-refundable. Substitutions may be made at any time at no additional charge.

Contact Details


Meddev Solutions, 30 Monaghan Street, Newry Co. Down, BT35 6AA, N.Ireland GBR