Training
Software development basics for regulatory professionals
This training focusses on XXX and XXX, and will make sure that you will know all the basics of SDMD Regulatory Insights
Training
Software development basics for regulatory professionals
This training focusses on XXX and XXX, and will make sure that you will know all the basics of SDMD Regulatory Insights
The course at a glance
What you’ll learn:
- Overview of the regulatory landscape
- Only the relevant sections of the standards
- Impact on your software development practices
For who?
- Software Engineers
- Project Owners
- Business Analysts
- Functional Analysts
- Project Managers
- ISO13485
- IEC 62304
- EU MDR
- FDA CFR
- ISO13485
- IEC 62304
- EU MDR
- FDA CFR
UPCOMING TRAININGS
In-depth regulatory standards for medical devices
(not software specific)
+5 more
UPCOMING TRAININGS
In-depth regulatory standards for medical devices
(not software specific)
Course Content
Course content
Part 1 - Regulatory overview
ISO 13485
ISO 13485 specifies requirements for a quality management system for medical device manufacturers to ensure consistent design, development, production, installation, and delivery of safe and effective products.
Part 1
Regulatory overview
Part 1
Regulatory overview
ISO 13485
ISO 13485 specifies requirements for a quality management system for medical device manufacturers to ensure consistent design, development, production, installation, and delivery of safe and effective products.
ISO 13485
IEC 62304 specifies the software life cycle processes for medical device software, including planning, design, implementation, testing, and maintenance, to ensure the safety and effectiveness of the software.
EU MDR
The EU MDR requires medical device software to meet specific regulatory requirements, including risk management and clinical evaluation, to ensure its safety and performance as an integral part of the medical device, focussing on EU regulations.
FDA CFR
The FDA CFR provides regulatory requirements for medical device software, including design controls, software validation, and risk management, to ensure its safety and effectiveness, with a focus on US regulations.
Part 2
Impact on your software development practices
Part 2
Impact on your software development practices
Testing Impact
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Design and then Develop
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Architecture
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Team impact
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Ready to upskill?
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TRUSTED BY
About our trainers
GILIAM GANZEVLES
Giliam has 25+ years of experience in the design industry – currently championing creative leadership and shaping the product teams at HUGE INC. He has planned many workshops in his life so he can give your perfectly educational workshops.
GILIAM GANZEVLES 2
Giliam has 25+ years of experience in the design industry – currently championing creative leadership and shaping the product teams at HUGE INC. He has planned many workshops in his life so he can give your perfectly educational workshops.
About our trainers
GILIAM GANZEVLES
Giliam has 25+ years of experience in the design industry – currently championing creative leadership and shaping the product teams at HUGE INC. He has planned many workshops in his life so he can give your perfectly educational workshops.
GILIAM GANZEVLES 2
Giliam has 25+ years of experience in the design industry – currently championing creative leadership and shaping the product teams at HUGE INC. He has planned many workshops in his life so he can give your perfectly educational workshops.
Other relevant trainings
We offer other workshops that gives a deepdive into the modules talked about in this general introduction course.
Software development basics for regulatory professionals
This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.
Usability Engineering according to IEC 62366
This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.
In-depth regulatory standards for medical devices
This workshop will provide a comprehensive understanding of the regulatory standards and requirements for medical devices, covering topics such as design control, risk management, quality system regulations, and post-market surveillance.