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AI/ML Compliance - Software Solutions & Services - QbD Group

AI/ML Compliance

In the rapidly evolving world of Artificial Intelligence (AI) and machine learning (ML), developing software solutions that meet regulatory standards is crucial. Whether you're developing AI models for medical devices, or in vitro diagnostic (IVD) systems, compliance with the latest standards and regulations is paramount.

At QbD Group, we understand the complexities of these requirements and offer comprehensive AI/ML compliance support to help you shorten your path to market.

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What is AI/ML compliance?

Data governance alone is no longer sufficient to address the unique challenges posed by AI. AI systems often operate in a black-box manner, making it difficult to trace their decision-making processes and potential biases. The lack of transparency and interpretability in AI models raises concerns about fairness, accountability, and ethics. 

AI/ML Compliance encompasses data governance while extending its scope to tackle specific AI-related issues. Key components of AI governance include algorithmic transparency, explainability, fairness, accountability, and compliance with AI-related regulations. The main driver of this compliance offering is the AI Act.

Why is AI/ML compliance important?

Ensuring compliance in AI and Machine Learning (AI/ML) is essential for various reasons, particularly in the life sciences, where data integrity and patient safety are paramount. With the advent of regulations such as the AI Act, compliance is not just a legal obligation but a cornerstone for building trustworthy and effective AI solutions.

Ethical use of AI

Ethical use of AI

Compliance ensures ethical operation of AI/ML-driven IVD and MD systems, protecting against biases, discrimination, and privacy breaches that could impact patient care and data security.

Risk mitigation

Risk mitigation

Effective AI/ML compliance frameworks minimize data breach risks, regulatory issues, and reputational damage, while protecting patient data integrity.

Trust & accountability

Trust & accountability

Responsible AI/ML use builds trust, crucial for fostering adoption, enabling collaboration, and supporting innovation in regulated data-driven environments.

How we approach AI/ML compliance

  • We start by looking at how you are currently working and which tools you are using. This can be performed through a design study or be the first step in a project.
  • In a second step procedures will be written to build the bridge between the compliance to the regulations and the business efficiency as it is performed at the client.
  • In the third step, we give advice and can review the technical documentation of your product(s) related to data and AI governance. 


AI/ML compliance is an emerging field driven by the recently published AI Act and ensures the latest state-of-the-art standards are used for product acceptance by a notified body.

Overall, AI/ML compliance is essential for fostering a culture of responsible data stewardship, driving innovation, and achieving sustainable business growth in the digital age. 

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AI medicine

Why partner with QbD Group?

AI/ML compliance is mandated by the regulations (MDR, IVDR, and upcoming AI Act) and verified by the notified bodies.  

You still have the choice of how to integrate your way of working and the tools you use as part of the data and AI governance. QbD Group can give strategic advice and support to ensure both compliance and business efficiency. There are multiple standards in development that can and will be used to ensure we remain state-of-the-art in AI/ML Compliance. 

You can schedule a consultation with our experts. During this session, we will assess your specific needs, discuss implementation strategies, and provide insights into how our services can benefit your organization.

Contact us today to take the first step towards effective data and AI governance.

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AIML compliance

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Get in touch

We understand the complexities of AI/ML compliance and are here to guide you through every step. Whether you need assistance with AI governance, data transparency, or aligning with the latest AI Act standards, our experts are ready to support you.

Schedule a consultation today to discuss your specific needs! 

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