OUR SERVICES
Trainings, consulting and software development
Our expertise helps medical device manufacturers and other health tech organizations.
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.
Not sure what is right for you?
TRAININGS & WORKSHOPS
CONSULTING
SOFTWARE DEVELOPMENT & UX
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.
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
In-depth regulatory standards for medical devices
(not software specific)
UPCOMING TRAININGS
In-depth regulatory standards for medical devices
(not software specific)
Consulting
Our consulting expertise includes regulatory compliance, risk management, and quality assurance for medical devices. We can help you make transition from unregulated software development to compliant processes under IEC 62304. We can custom write your software SOP’s tailored to how your team works. We offer templates for all required software documentation.
- From classic software development to IEC 62304 compliant
- SOP’s customized to your current development practice
- Template based setup of all documentation
“Through my years of UX experience, I have a deep understanding of Usability Engineering for medical devices”
Giliam Ganzevles
Consulting
Our consulting expertise includes regulatory compliance, risk management, and quality assurance for medical devices. We can help you make transition from unregulated software development to compliant processes under IEC 62304. We can custom write your software SOP’s tailored to how your team works. We offer templates for all required software documentation.
- From classic software development to IEC 62304 compliant
- SOP’s customized to your current development practice
- Template based setup of all documentation
“Through my years of UX experience, I have a deep understanding of Usability Engineering for medical devices”
Giliam Ganzevles
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.
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
- Fully IEC 62304 compliant development
- Integration with your eQMS
- QA testing (verification) and documentation
Explore our latest
Reliability in medical devices
When we are dealing with medical devices, we expect them to be reliable. But what is reliability in these devices? Reliability is not trust When
The how and the what of external software components (SOUP or OTS software) in medical devices
Currently, when developing software for medical devices, there are two sets of rules that deal with external software components: IEC 62304 and the FDA guidance
The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)
The regulations around external software components are mostly risk-averse and safety oriented. This negates the benefit of updating components frequently. In this article, we look
Navigating the Waters of Risk Management for Medical Devices
Introduction In the realm of healthcare, patient safety is paramount, and this holds especially true for medical devices. The development, manufacturing, and distribution of medical