Seminar / Workshop „Risk Management and ISO 14971 (English)“

Next Seminar
10. - 11.
May 2021
Risk Management and ISO 14971 (English)
Speaker: Christian Rosenzweig
Location: Online Seminar
Language: English
Free seats available
Your Price
1160 €
plus VAT.
1380,40 € (incl. VAT.)

Goals

Risk management is the linchpin of medical device law. In this workshop, you will learn to avoid risk management mistakes that can lead to problems in audits and delays in the "approval" of your medical devices.

Content:

 

This seminar thus provides you not only with a comprehensive knowledge, but also with the skills to create and review the risk management files for your medical devices and to coordinate the activities related to risk management.

Here you will find more information about the next dates and costs. If nothing else is noted in the table on the overview page, there are still places available.

Agenda

The seminar lasts two days, with a focus on practical relevance. The lectures alternate with case studies and numerous exercises. We are happy to discuss your specific files and subject them to a "quick check" if desired.

 

Time Topic
Day 1  
  09:00  Start
  09:00 Introduction, expectations
  09:30 Relevant standards, laws, directives, regulations and other requirements and their context.
  10:30 Break
  10:45  Definitions of terms
  11:30 Risk evaluation, Risk acceptance matrix
  12:30 Lunch break
  13:00 Case Study "Creating a Risk Acceptance Matrix"
  14:30 Break
  14:45 Methods for hazard analysis (FMEA, FTA, PHA)
  15:45 Case study “Hazard and risk analysis”
  16:45 Summary and answering questions
  17:00 End of day 1
Day 2  
  09:00 Start
  09:00 Updating expectations, answering open questions
  09:30 Risk control: measures, safety-critical architectures
  10:30 Break
  10:45 Risikomanagement im Produktlebenszyklus: development & post market surveillance (vigilance and reporting system)
  12:00 Lunch break
  13:00 Case study „Risk control and post market observation“
  14:30 Break
  14:45 Special topics: Special features of software, review of sample files
  15:30 Open questions
  16:00 Break
  16:15 Exam (participation optional)
  16:45 Farewell
  17:00 End of seminar

Target group

The seminar is intended for persons involved in the development of medical devices in compliance with standards, in particular for 

The seminar is also suitable for beginners and teaches (also) the basics of risk management. However, in the course of this intensive workshop, participants reach a higher advanced level and work on challenging tasks.