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

Next Seminar
15. - 16.
March 2022
Risk Management (Englisch)
Speaker: Christian Rosenzweig
Location: Online Seminar
Language: English
Free seats available
Your Price
1360 €
plus VAT.
1618,40 € (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:

  • Regulatory Requirements
    You know the relevant standards, laws, directives, regulations and guidelines as well as their interaction.
  • Risk acceptance
    You are able to determine acceptable and unacceptable risks for your medical device.
  • Risk analysis
    You can apply risk analysis procedures such as PHA, FMEA and FTA and systematically identify hazards for your medical device.
  • Risk control
    You know what approaches are available to manage the risks posed by your medical device and thereby maximize the safety of your patients.
  • Risk management documentation and audit
    You are able to create an ISO 14971 compliant risk management file and know the typical findings in audits when creating the documents.
  • Risk management in design controls and product life cycle
    You know how to integrate the activities of the risk management process into your development process and how to establish market surveillance in compliance with the law.
  • Special considerations for software
    You have answers to software-specific questions on, for example, probability estimation, software security classes, and typical risks posed by software.

 

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.

 

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

Target group

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

  • Risk managers
  • Safety officers for medical devices, persons responsible for regulatory compliance
  • Developers, system and software architects
  • Project managers
  • Responsibles for Regulatory Affairs and Quality Management

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.