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MindPro is a certified medical device

- your guarantee of quality and safety

Book gratis demo

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:

Safe to use
Provides accurate and reliable results
Complies with GDPR and data security regulations
Has clear clinical evidence for its function

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.

International standards we follow:
  • 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
This ensures that MindPro is not only an effective tool, but also a solution that takes patient data and healthcare responsibility seriously.

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.

MindPro on mobile

Quality and ease of use

We follow IEC 62304, ISO 13485 and IEC 62366 standards to ensure quality and ease of use.

Risk management

ISO 14971 ensures that we proactively work to minimize risks when using our software.

Continuous improvement

We document, evaluate and continuously improve the solution to ensure maximum value and security.

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Medical Device Aftercare Trivselsundersøgelser Om os Kontakt

Kontakt info

Hvidkærvej 42, 5250 Odense SV
+45 51 90 05 02
kontakt@medicapro.dk
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