MindPro is a certified medical device
- your guarantee of quality and safety
What is MDR - and why is it important?
The Medical Device Regulation (MDR) is the EU's current regulation for medical devices and aims to protect patient data and ensure that healthcare technology solutions meet strict quality and safety standards. In practice, this means that software like MindPro undergoes documentation, testing and continuous monitoring to ensure that it:
This is how we do it at our company
We have a systematic quality management system in place and focus on risk management, usability and documentation to make our software MDR compliant.
- IEC 62304 - Software development for medical devices
- ISO 13485 - Quality management in healthcare
- IEC 62366 - Usability in medical software
- ISO 14971 - Risk management for medical devices
Benefits for our customers
When you choose an MDR-certified solution like MindPro, you get more than a digital tool - you get:
Safety and security
Our platform protects sensitive data and meets the strictest requirements.
Effectiveness
You get proven impact and transparency in functionality and results.
Security & Professionalism
Our regulatory compliance reduces the risk of legal and clinical errors and shows that we work responsibly with healthcare technology.
Our commitment to quality and safety
Our commitment to the MDR is not just a formal certification - it is a core value in our work. It means that we:
- Develop with quality and the user in focus
- Continuously monitor and update our solution
- Include healthcare knowledge throughout the development process
- Document, evaluate and continuously improve
The result? A tool that is both clinically useful, user-friendly and documented safe.
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We follow IEC 62304, ISO 13485 and IEC 62366 standards to ensure quality and ease of use.
ISO 14971 ensures that we proactively work to minimize risks when using our software.
We document, evaluate and continuously improve the solution to ensure maximum value and security.