Quality Training

Proactive Risk Management in Medtech: Staying Ahead of Regulatory Challenges

In the fast-paced Medtech sector, effective risk management isn’t just about meeting regulatory requirements, it’s about safeguarding patients, ensuring product quality, and enabling market success.
This comprehensive programme gives participants a deep, practical understanding of ISO 14971 – Risk Management for Medical Devices and how to apply it proactively in real-world situations.

Over four interactive online sessions, you’ll explore the full risk management process, from identifying hazards and assessing risks, to implementing control measures and maintaining compliance with evolving regulations such as MDR, IVDR, and FDA requirements. You’ll also gain hands-on familiarity with the tools, techniques, and documentation needed to manage risk throughout the medical device lifecycle.

Whether you work in R&D, Quality, Regulatory, Operations, Clinical, or Leadership, this course will equip you with the knowledge and confidence to anticipate challenges, make informed decisions, and stay ahead of regulatory demands.

Upcoming dates:
Tuesday 21st, Wednesday 22nd, Tuesday 28th & Wednesday 29th of October 2025

Objectives

• Provide learners with a comprehensive understanding of ISO 14971 - Risk Management for Medical Devices and how to apply this correctly within the Medical Device Industry.
• Equip learners with the necessary understanding and confidence to apply a proactive approach to risk management within the Medical Device Industry (in the context of ISO 14971).
• Familiarise learners with the relevant regulations and tools necessary to be effective in applying a proactive approach to risk management within the Medical Device Industry.
• Apply one or more techniques that support risk analysis​
• List the documents required for the risk file and know when updates are needed​
• Identify the role of ISO/TR 24971 in risk management​
• Fundamentals of Combination Product Risk Management
  

Learning Outcomes

Understanding of:

• the purpose, scope, and structure of ISO 14971
• the key terminology used throughout ISO 14971
• The 60601/61010 series
• Biocompatibility (EN ISO 10993)
• the core elements of an effective risk management process
• some risk analysis techniques • the documents required for the risk file and triggers to update the same
• the role of ISO/TR 24971 in risk management • the fundamentals of Combination Product Risk Management
  

Content includes

Day 1 – Introduction to risk & risk management (4 hours)

• Risk definitions
• Understanding misuse
• Introduction to ISO 14971:2019
  • Risk management process
  • Management responsibilities
  • Competence of personnel
  • Risk management planning
  • Risk Management File
• Risk acceptability criteria
• Q&A
  

Day 2 – Understanding risks (4 hours)

• Risk analysis
• Risk estimation
• Risk evaluation
• Q&A
  

Day 3 – Requirements for mitigating and managing risks (4 hours)

• Risk control & risk control measures
• Overall residual risk
• Risk review
• Production and post-production activities
• Q&A
  

Day 4 – Risk management tools and supports (4 hours)

• Risk fundamentals for Combination Products
• Risk tools
• Risk and the MDR / IVDR
• Risk and its links to other processes and standards
• Q&A

Who should attend

Professionals in the Medtech industry, including (but not limited to) those in the following functions:

• R&D – To integrate risk management into product design and innovation.
• Quality & Regulatory – To ensure compliance with ISO 14971, FDA, MDR, and other regulatory requirements.
• Operations & Supply Chain – To proactively identify and control risks in processes and supply chains.
• Clinical & Post-Market Surveillance – To assess and manage risks related to patient safety and real-world product use.
• Business & Leadership Roles – To understand how risk management supports strategic decision-making and market success.

  Upcoming dates:

  Location

  Dates

  
  
  Online, Online

  21, 22, 28, 29 October 2025

  Book now