Seminar / Workshop "Risk Management & ISO 14971"

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.

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 

  • 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.

Question, Further Information, In-house Seminars

Do you have any questions or suggestions? Do you want to carry out the seminar as an inhouse seminar to tailor the topics to your individual needs? Contact us directly. We are looking forward to it!

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