Compliance

At radiomics.bio, safety and trust are our top priorities. Quality Assurance (QA) plays a vital role in achieving this, ensuring that our services and medical devices meet the highest standards of safety, reliability, and effectiveness.

  1. Risk management: 

    Processes are designed to identify and mitigate potential risks, focusing on patient safety and a consistently reliable service.
  2. Compliance: 

    We comply with ISO 13485 and ISO 27001 standards, and we follow the guidelines of MDR and FDA.

  3. Reliable Performance: 

    Our team works tirelessly to ensure that our services and devices perform accurately and consistently, providing you with reliable results every time. We base our activities on rigorous scientific evidence and on clinical validation.
  4. Cost Efficiency:
    
By preventing defects and ensuring compliance, QA plays an important role in offering high-quality services and devices at competitive prices.
  5. Building Trust: 

    Consistently delivering high-quality services and products enhances our reputation and builds trust with the healthcare industry.
  6. Information Security: 

    Protecting personal and medical information is crucial. Our processes include stringent information security measures to ensure that data is secure and remains confidential.
  7. Continuous Improvement: 

    QA is not just about maintaining standards; it’s also about innovation. Our QA processes help us identify areas for improvement, leading to better and more advanced medical devices.

    By prioritizing QA, we ensure that our services and medical devices are not only safe and effective but also reliable and trustworthy.

Our Certifications:

Since January 2022, radiomics.bio’s quality management system (QMS) for medical devices and services is ISO 13485. Our ISO 13485 certification covers the design and development of Software as a Medical Device used for the diagnosis, prognosis or prediction of disease progression which are typically assessed through routine clinical imaging.

As of January 2023, radiomics.bio is also ISO 27001 certified. This certification applies to the analysis of medical information for commercial client services and for designing and developing software for medical devices. This ensures the practices we have in place protects the integrity, confidentiality and availability of information and data that we process and allows us to be resilient in the face of cyber-attacks and other data security related risks.