​At Mindmore, we are committed to maintaining the highest standards of information security, quality, and regulatory compliance. We actively ensure that our processes and products align with international standards and regulations.

 

ISO 27001 – Information Security

We are aligned with ISO 27001 and have implemented an Information Security Management System (ISMS) to protect sensitive data and ensure robust security measures. Our systems and processes comply with ISO 27001 requirements, including:

• Risk Management – Identifying, assessing, and mitigating security risks.

• Encryption and Data Protection – Secure storage and transfer of data following industry standards.

• Access Control and Authentication – Two-factor authentication (2FA) and strict access management.

• Logging and Monitoring – Continuous monitoring of system activities to ensure security and traceability.

 

ISO 13485 – Quality Management for Medical Devices

We are in the process of obtaining ISO 13485 certification, implementing a quality management system that ensures our medical devices meet regulatory requirements and industry standards. This includes:

• Documentation Management – Structured and traceable documentation of product development and manufacturing.

• Risk Management – Systematic processes to identify and mitigate risks throughout the product lifecycle.

• Product Development and Validation – Strict requirements for testing and validation of our products.

 

MDR – Medical Device Regulation
We are actively working with the EU's Medical Device Regulation (MDR 2017/745) and are in the process of certification according to this regulation. According to the original regulation, all medical devices were to be certified under the MDR by May 2024. However, the regulation has been updated, and for Class IIa products, certification must now be in place by December 2028.

We comply with the MDR by working systematically with:

• Technical documentation – Documentation according to the formal requirements of the MDR.

• Risk management and clinical evaluation – Assessment of the safety and performance of our products.

• Post-market surveillance (PMS) – Continuous monitoring and improvement based on user data and regulatory requirements.
  
  We have been applying the regulation since the fall of 2023, and our certification process is ongoing. We expect to be certified in 2025.

 

If you have any questions about our compliance process, please feel free to contact us for more information.