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Medical Device Risk Management
Medical Device Risk Management

Course Description

This 3-half-day course covers all required elements of ISO 14971. You will be able to identify links between standards and regulatory requirements as well as gain tools for management. The course is ideal for anyone in a quality, regulatory affairs, engineering or manufacturing.  

Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!)

  • ISO14971, EU MDR/IVDR, and US FDA
  • Risk Analysis, Evaluation & Control
  • The Risk Management File
  • Regulatory & Notified Body Expectations
  • Post-market and Risk Management
  • Benefit/Risk & Residual Risk Analyses
  • Understand, and interpret key regulatory requirements and standards for risk management:
  • EU MDR
  • FDA 21 CFR
  • ISO 14971
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Identify the links between ISO 14971, MDR 2017/745 and IVDR 2017/746
  • Outline the stages of the risk management process
  • Define the key deliverables of the risk management process
  • Apply risk management principles within your organization

Medical Device Risk Management

15 - 17 October 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

START TIMES

1:00 PM Vienna time

12:00 PM London time

7:00 AM New York time

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Course Description

This 3-half-day course covers all required elements of ISO 14971. You will be able to identify links between standards and regulatory requirements as well as gain tools for management. The course is ideal for anyone in a quality, regulatory affairs, engineering or manufacturing.  

Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!)

  • ISO14971, EU MDR/IVDR, and US FDA
  • Risk Analysis, Evaluation & Control
  • The Risk Management File
  • Regulatory & Notified Body Expectations
  • Post-market and Risk Management
  • Benefit/Risk & Residual Risk Analyses
  • Understand, and interpret key regulatory requirements and standards for risk management:
  • EU MDR
  • FDA 21 CFR
  • ISO 14971
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Identify the links between ISO 14971, MDR 2017/745 and IVDR 2017/746
  • Outline the stages of the risk management process
  • Define the key deliverables of the risk management process
  • Apply risk management principles within your organization

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Medical Device Risk Management

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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