Trainings and workshops
Knowledge is key for levelling up your team
Is your team fully trained?
Trainings and workshops
Knowledge is key for levelling up your team
Is your team fully trained?
Our trainings
Our workshops on regulatory compliance in software development cover a range of topics, including medical devices, software, cybersecurity, providing a detailed understanding of the regulatory landscape and requirements for health tech products.
Attendees will gain valuable knowledge and practical tools to ensure compliance and mitigate risks in their organizations.
QUESTIONS OR SPECIFIC WISHES?
Software Development for Medical Devices
THIS TRAINING IS FOR:
- Software Engineers
- Project Managers
- Product Owners
- Functional Analysts
Cybersecurity according to the FDA guidance 2023
Big changes are coming in how the FDA looks at cybersecurity. In the next few years, this will have a massive impact on how your team handles cybersecurity. This training goes into the FDA guidance document and outlines what your team needs to do and how to document it.
THIS TRAINING IS FOR:
- Software Engineers
- Project Managers
- Software Architects
- DevOps Engineers
The IEC 62304 standard in-depth
This training focuses 100% on IEC 62304 in great detail. We look into software requirements, specifications, testing and verification, software release, risk management and software maintenance. A unique detailed deep-dive!
Â
Â
Â
THIS TRAINING IS FOR:
- Software Engineers
- Project Managers
- Product Owners
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.
THIS TRAINING IS FOR:
- 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.
THIS TRAINING IS FOR:
- 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.
THIS TRAINING IS FOR:
- Software development professionals
- New QA/RA professionals
- Medical device teams
About our trainers
Our team combines extensive software development experience with regulatory knowledge, IT expertise, and UX expertise. We can bridge the gap between software development and regulatory in your organization and help you take your medical device to the next level.
BIOGEN
We helped to increase of development velocity by simplifying their SOP’s, reducing documentation burdens and improving processes.
About our trainers
Our team combines extensive software development experience with regulatory knowledge, IT expertise, and UX expertise. We can bridge the gap between software development and regulatory in your organization and help you take your medical device to the next level.
NEUROVENTIS
We helped to set up their first development processes and documentation, allowing them a quick start in compliant software development.
BIOGEN
We helped to increase of development velocity by simplifying our SOP’s and reducing documentation burdens.
REPLASIA
We helped Replasia start their journey towards a certified SaMD medical device.
TRUSTED BY
Package deals
We understand that sometimes it is not just one course you need. We offer package deals. Get 10% discount on 3 trainings or more.
Package deals
We understand that sometimes it is not just one course you need. We offer package deals. Get 10% discount on 3 trainings or more.
Software development basics for regulatory professionals
Usability Engineering according to IEC 62366
In-depth regulatory standards for medical devices
- Combine the trainings you need
- On-premise or in our offices
- Get your team up to speed fast
- Combine the trainings you need
- On-premise or in our offices
- Get your team up to speed fast