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PRO-LIANCE CORE LEARNING
Risk Management for Medical Devices – Practical Implementation in Accordance with ISO 14971
Identify, evaluate and control risks throughout the product lifecycle

Duration

4 hours

Format Online

Language English

Challenges Addressed

  • How can a risk management process be effectively established and maintained?
  • How can hazards, risks and risk control measures be evaluated in a clear and traceable way?
  • How should residual risks that are difficult to assess or accept be addressed?
  • How can PMS and post-production information be fed back into the risk management process?   
  • How can documentation be kept from becoming a box-ticking exercise with little practical value?

After the Training, Participants Will Be Able To

  • Apply the key requirements of ISO 14971 to their own processes.
  • Systematically identify, analyze and evaluate risks.
  • Define appropriate risk control measures and assess their effectiveness.
  • Evaluate residual risks and the benefit-risk ratio in a clear and traceable manner.
  • Clearly and traceably evaluate residual risks and the benefit-risk ratio
  • Link risk management with PMS and other relevant processes. 

Agenda

  • Risk management fundamentals and regulatory context
  • Risk Management Plan and Risk Management File  
  • Hazard identification and risk analysis
  • Risk evaluation and risk control
  • Residual risks and benefit-risk evaluation
  • Interfaces with product development, clinical evaluation and PMS
  • Common mistakes and practical implementation within the organization 
 
 
 
Duration: 4 hours | Language: English | Modality: online (via Teams)

Practical Application

Work through a case study involving a specific medical device, jointly evaluate risks and risk control measures, discuss common practical questions, and use checklists and templates.

Target Audience

Professionals in Regulatory Affairs, Quality Management, Product Development, Clinical Affairs and post-market surveillance (PMS), as well as those responsible for medical device risk management. 

Prerequisites

A basic understanding of medical devices and the regulatory or quality management processes used within an organization is helpful, but no in-depth prior knowledge is required. 

Why attend?

Participants will learn to use risk management not merely as a formal documentation exercise, but as a practical tool for safer products, robust evidence, and better-informed regulatory decisions. 

PRICING AND REGISTRATION

Special offer for companies

Special offer for companys registering more than two participants (440.00 €/person excl. VAT) per company!

Early bird fee

Register 8 weeks prior to event and profit from our early bird fee (440.00 €/person excl. VAT)!

Normal price

Standard registration fee: 490.00 € excl. VAT

29 October 2026

Time 9:00-13:00 (CET)
REGISTER

03 February 2027

Time 13:00- 17:00 (CET)
REGISTER

03 March 2027

Time: 9:00-13:00 (CET)
REGISTER

In-house

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FAQ

WHO IS THIS TRAINING FOR?

This training is designed for professionals in Regulatory Affairs, Quality Management, Product Development, Clinical Affairs and Post-Market Surveillance (PMS), as well as anyone responsible for medical device risk management. A basic understanding of medical devices and regulatory or quality management processes is helpful, but no in-depth prior knowledge of ISO 14971 is required.

You will learn how to apply the key principles and requirements of ISO 14971 to your own risk management processes. The training covers systematic hazard identification, risk analysis and evaluation, risk control measures, residual risks and benefit-risk evaluation. You will also learn how to establish clear and traceable documentation and connect risk management with product development, clinical evaluation and PMS.

The training focuses on practical implementation rather than risk management as a documentation exercise. You will work through a medical device case study, jointly evaluate risks and risk control measures, discuss common practical challenges and use checklists and templates. This hands-on approach will help you apply risk management as a practical tool for safer products, robust evidence and better-informed regulatory decisions.

ADDITIONAL INFORMATION

  • Registration and event will be managed via Microsoft Teams. Billing and cancellation information will be sent to you via a separate email after registration.
  • Please note that the training will only take place if the minimum number of 4 participants is reached.
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