Seminar / Workshop “Risk Management & ISO 14971”

Learning objectives of the two-day seminar

Risk management is a pivotal issue of medical device law. In this seminar, you will learn to avoid making risk management errors resulting in audit issues and potentially delaying the authorization of your medical product.

  • Regulatory fundamentals
    You will learn about relevant standards, laws, regulations, directives, and guidelines addressing risk management as well as about their interplay.
  • Risk acceptance
    You will be able to determine the acceptable and unacceptable risks of your medical device.
  • Risk analysis
    You will be able to apply risk assessment procedures such as PHA, FMEA, and FTA and to systematically identify hazards caused by your medical device.
  • Risk minimization
    You will know the approaches of controlling your medical device’s risks being at your disposal to maximize your patients’ safety.
  • Risk management dossier and audit
    You will be able to compose a risk management file compliant with ISO-14971. You will know typical mistakes when creating documents for audits.
  • Managing risks along the development process and product life-cycle
    You will know how to integrate risk management activities in your development process and how to integrate lawful market surveillance.
  • Special considerations concerning software
    You will get answers to questions specifically concerning software, e.g. assessing the classification and typical risks arising from the software.

This seminar not only imparts comprehensive knowledge but also the skills needed to compile and assess risk management files for your medical devices and to coordinate activities of risk management.

Contents and Program Schedule

The seminar lasts two days. Practical relevance is paramount. The lectures are alternating with case studies and several exercises. We are pleased to even discuss specific files and subject them to a “Quick-Check”.

Time Topic
Tag 1  
  09:00  Start
  09:00 Expectations, introduction
  09:30 Relevant standards, laws, regulations, other guidelines, and their interactions
  10:30 Break
  10:45  Definitions
  11:30 Risk policy, risk acceptance matrix
  12:30 Lunch
  13:00 Case study “compiling a risk acceptance matrix”
  14:30 Break
  14:45  Approaches to risk analysis (FMEA, FTA, PHA)
  15:45 Case study “hazard and risk analysis”
  16:45 Summary and Q&A
  17:00 End
Tag 2  
  09:00 Start
  09:00 Updating expectations, answering unresolved questions
  09:30 Risk mitigation, measures, safety-critical architecture
  10:30 Break
  10:45 Risk management along with the product life-cycle development and market surveillance (vigilance and reporting system)
  12:00 Lunch
  13:00 Case study “risk management and post-market surveillance”
  14:30 Break
  14:45 Special topics: special considerations concerning software, review of sample files
  15:30 Q&A
  16:00 Break
  16:15 Exam (participation is optional)
  16:45 Closing of the seminar
  17:00 End

We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.

Target Audience

The seminar addresses everyone involved in software development for medical devices compliant with standards, especially

  • Risk Managers
  • Safety Officers
  • Developers, system and software architects
  • Project Managers
  • Persons in charge of regulatory affairs and quality management

The seminar is also suited for beginners and (also) imparts the foundations of risk management. However, over the course of this intensive workshop, participants reach an advanced level and deal with demanding tasks.

The question, Further Information, In-house Seminars

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