As experts in medical product technology, we support the verification process from individual modules (software, hardware, mechanics) to functional testing of the entire system. Since we support projects during the entire product life cycle, we know where verification problems may occur and can precisely focus on resolving them and checking the results. This smooths the way to getting quick market approval for your product.
We know how efficient testing works. Our experience helps us find the best solution for verification with a reliable estimate of the timeline.
The verification process for medical products demands the corresponding requirements engineering and risk management activities. These disciplines are also part of our expertise. Our test strategies are compliant with ISO 14971 for risk management.
Advantages of konplan
- Expert knowledge in verification and testing
- Specialists for medical technology. We know all the applicable regulations for medical products and their production environments down to the last detail.
- Our team covers all fields of technology. That is why we understand the interaction between hardware, software, and firmware very well.
- Competent requirements engineering and risk management according to ISO 14971 mean additional security for you.
We are here for you – send us your request!
Developing together! We put your ideas into practice and accompany your projects until they are ready for the market. Get in touch with our experts now.
Additional relevant services
Revolutionary insulin pump system
With medical technology know-how, we were able to support PharmaSens with the successful FDA submission of their insulin pump system.
Validation / Qualification
Compliant and efficient
Software in the Medtech industry (IEC 62304)
Always compliant and efficient
Risk Management
Risks always under control
Requirements Engineering
Requirements clearly elaborated
DevOps, CI/CD
Efficient software development
