- EU MDR and medical device software and software as medical device
- Regulations, standards and guidance documents
- European harmonized standards
- International guidance documents
- Overview structure EN 62304
- Scope and Chapter structure
- Medical device software terminology
- Medical Device Software (MDSW), Software as Medical Device (SaMD)
- Terminology EN 52304 clause 3
- Software lifecycle processes according EN 62304 and EU MDR 2017/745 including testing
- Regression testing
- Test methods
- SOUP
- CE-Marking
- EU MDR 2017/745 GSPR
- EU MDR 2017/745 Annex VIII
- EN 62304-chapter structure
- EN 62304 – development process
- EN 62304 – maintenance process
- Software safety classification
- Software lifecycle and risk classes – activities
- Short outlook to US FDA
- Software design
- Unit implementation
- Integration and Integration testing
- Testing techniques
- System testing
- Software release
- Software maintenance plan
- Problem and modification analysis
- Modification implementation
- Risk management
- Software configuration
- Change control, records and trends
- Interface to EN 60601-1
- Artificial Intelligence (AI) & Machine Learning (ML)
- AI and ML under EU MDR 2017/745 and US regulation, approach for registration process
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- Certification
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).Cancellations and substitutions for In-person Seminars:
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