The IEC 62304 standard in-depth
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
- Overview of the regulatory landscape
- Only the relevant sections of the standards
- Impact on your software development practices
- Software Engineers
- Project Owners
- Business Analysts
- Functional Analysts
- Project Managers
UPCOMING TRAININGS
Course Content
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.
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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OUR EXPERTISE
Wessel has 25+ years of software development as well as 6 years of medical device development. His clients describe him as 80% software development expert, 20% regulatory expert. He combines both domains and bridges the gap between development and regulatory teams.
Bianca is an expert in strategic communications with 20+ years of professional experience.
Ivo has experience in both IT infrastructure as well as software development, bridging that gap. He’s worked as Operations Manager, Project Manager, and Consultant.
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
In this training, we explain the basics of software development in terms of process, technology and how it is delivered, tested and deployed.
- Regulatory Professionals
- QA/RA Managers
- Consultants
Usability Engineering according to IEC 62366
Usability Engineering according to IEC 62366 is a often neglected subject. In this training, we deep-dive into UX and Usability Engineering for medical devices.
- UX Engineers
- Functional Analysts
- Software Engineers
- Designers
In-depth regulatory standards for medical devices
In this training, we look at the entire regulatory landscape for medical devices, not limited to software. We also cover hardware standards, electricity and radiation regulations.
- Software development professionals
- New QA/RA professionals
- Medical device teams