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ABOUT OUR TRAINERS

What we offer

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.

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Software Development for Medical Devices

In this training, we do a deep dive into the regulations that are relevant for software development for medical devices, including IEC 62304, ISO 60601-1 (for SiMD), FDA guidance documents, and EU guidance documents. This includes all the necessary processes, documentation, and reviews. We also look into the impact on your software development – including velocity, team composition and software release cadence.

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THIS TRAINING IS FOR:
  • Software Engineers
  • Project Managers
  • Product Owners
  • Functional Analysts

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!

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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.

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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.

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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.

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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.

Meet our team
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.

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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.

Plan your program
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