Seminar Risk Management and ISO 14971 (2 days)
Create an ISO 14971-compliant and audit-proof risk management file without stress
This seminar provides you with comprehensive knowledge of risk management and the competence to coordinate all your company's risk management activities and create compliant risk management files for your medical devices.
Anmeldung zum Seminar Risikomanagement und ISO 14971 (zweitägig)
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Learn how to implement effective risk management according to ISO 14971 in your company
Among other things, you will learn how to define comprehensible risk acceptance criteria, systematically identify hazards, evaluate risks, and define suitable measures for risk control. Our expert will show you how to compile all this information quickly and compactly in your risk management file and check it for compliance.
100%
of the participants recommend
this seminar!
"The many examples from Christian Rosenzweig's wealth of experience and his extremely broad overview of the topic were impressive."
Get to know tried-and-tested strategies to be successful in audits and reviews
In contrast to a purely theoretical lecture, our trainer uses practical exercises and sample documents to help you transfer what you have learned directly into your everyday work and onto your devices. Instead of clinging to rigid plans and examples of little relevance, he explains the material using real devices and addresses your specific case.
Benefit from numerous tips, valuable insights, and the many years of experience of our expert
Unlike typical inspectors, our trainer does not just point out mistakes but uses his own daily work to teach you the best practices for creating precise and compliant risk management files. In this seminar, you will receive concrete guidance and precise answers to your questions so that you can pass your future audits and reviews successfully.
You can find more information about the seminar and the schedule in the information sheet:
Certificate
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
Further Information
- Regulatory framework in Europe with embedding of risk management
- Definitions according to ISO 14971 (with practical exercise)
- Risk policy and evaluation (with practical exercise)
- Risk analysis according to PHA (Preliminary Hazard Analysis)
- Risk analysis according to FMEA (Failure Mode and Effect Analysis)
- Risk analysis according to FTA (Fault Tree Analysis)
- Software-specific procedures
- Probabilities of technical faults and harm to people
- Practical exercise for risk analysis in small groups
- Risk control
- Risk management in the post-production phase
- Risk management files and the ISO 14971 standard itself
- Linking risk management with other processes (clinical evaluation and cybersecurity risk management)
- define comprehensible risk acceptance criteria.
- systematically identify hazards and assess risks.
- define suitable measures for risk control.
- create risk management files and check them for conformity.
- set requirements for post-market surveillance (PMS) and evaluate PMS data.
- Risk Manager
- Quality and Regulatory Affairs Manager
- Product Manager and Product Owner
- Employee in medical device development (software, electronics, mechanics)
- Person responsible for the production
- Employee of notified bodies and authorities
- Person Responsible for Regulatory Compliance (in accordance with Article 15 of the MDR or IVDR)
An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to seminare@johner-institut.de to find a solution.
Three days before the seminar, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.
At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.
Get to know your trainer
As an engineer for biomedical technology, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. As the person responsible for carrying out and guiding conformity assessment procedures in the EU and USA, he gained experience with all forms of audits and various markets (in particular, FDA and MDSAP). He was also an ISO 13485 quality management representative in a large corporation. As a sought-after expert, he assists our customers with strategy issues and the implementation of quality or regulatory affairs management. His focus is on the safety of medical devices, risk management, and IT security.
Are you familiar with our in-house seminars?
We are also happy to offer you our seminars as in-house seminars. Either online or at your premises, as required.
Please feel free to contact us.
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