BIOGEN
“Through my years of UX experience, I have a deep understanding of Usability Engineering for medical devices”
OUR SERVICES
Trainings, consulting and software development
Our expertise helps medical device manufacturers and other health tech organizations.
Our services
We offer consulting services for medical device software. Our services include comprehensive trainings and workshops and consulting services, as well as software development and UX, setting us apart from the competition.
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Trainings & Workshops
Our trainings and workshops cover all aspects of software development for medical devices, including the standards IEC 62304 and ISO 13485, as well as FDA regulations and the EUR MDR. In addition, we have focused trainings on subjects such as cybersecurity for medical devices, Usability Engineering (UX for medical devices) and many other topics.
UPCOMING TRAININGS
Software Development & UX
We offer a full range of software development, UX and design, and QA testing (verification) and compliant documentation. Our team of software engineers and UX designers work closely with clients to develop solutions that enhance the usability, reliability, and effectiveness of their products, in regulatory compliance.
Fully IEC 62304 compliant development
Integration with your QMS
QA testing (verification) and documentation
Explore our latest
Navigating the Waters of Risk Management for Medical Devices
April 8, 2026
Risk management in medical devices goes beyond compliance — it’s a continuous process of identifying, controlling, and monitoring risks throughout the product l
The how and the what of external software components (SOUP or OTS software) in medical devices
March 25, 2026
How SOUP and OTS software are defined in medical devices — and why documentation effort increases significantly with higher risk levels.
The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)
March 25, 2026
Strict medical software regulations are slowing down updates and innovation — especially for widely used open-source components.
Reliability in medical devices
March 24, 2026
What reliability really means in medical devices—and why it goes beyond trust, safety, quality, and regulation. A clear breakdown of how reliable systems are defined and evaluated in practice.