Artificial intelligence is opening up entirely new possibilities for medical technology: more precise diagnoses, more personalized therapies, and more efficient processes.
However, the journey from an initial idea to a market-ready AI product is complex. Technical challenges, clinical requirements, and a dense network of regulatory frameworks demand not only expertise, but also foresight and reliability.
Providers who want to succeed in this innovative environment need strong partners – such as seleon GmbH. Together, we bring medical AI to market safely and effectively. Our ambition is not only to overcome challenges but also to actively shape progress.Â
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Comprehensive Support Throughout the Entire Product Lifecycle
At seleon, we support our clients every step of the way in developing AI-based medical devices – from the first concept to post-market surveillance.
We assist in clearly defining the intended purpose, understanding user needs, managing clinical evaluations, and developing strategies for post-market monitoring.
All these aspects are crucial for ensuring that the product gains approval and performs reliably in the market.
In a previous article, we outlined how regulatory requirements can be practically implemented. You can find the full article here:
🔗 https://www.seleon.com/de/anforderungen-an-kunstliche-intelligenz-praktisch-umgesetzt/
This current article builds on that and shows what a safety-oriented development process for AI in medical devices should look like – and how cooperation with seleon is implemented in practice.Â
A Structured Development Process for Greater Safety
The starting point is a thorough requirements analysis.
Together with our clients, we clarify what clinical questions the AI is intended to answer, who the users are, and in what context the product will be used. These cornerstones form the foundation for subsequent software development.
Data management plays a central role.
In medical technology, data typically comes from clinical studies, which providers access through their networks with medical institutions or their own study centers.
Working with seleon ensures that this data is structured, prepared, and documented in full compliance with regulatory requirements.
We also ensure consideration of technical aspects such as data format, anonymization, and representation of all relevant patient groups. This prevents the model from disadvantaging specific groups or being limited to narrow subpopulations.
A transparent approach to potential bias and early identification of distortions are particularly important here.
Splitting data into training, validation, and test sets enables objective performance evaluation and prevents overfitting.Â
Clearly Defined Roles – Targeted Use of Expertise
Many of our clients have specialized research departments that explore architectures and initial models for AI applications in the medical field.
This early phase of research and model architecture remains deliberately with the client to protect and expand internal know-how.
In the subsequent product development phase, seleon takes over specific tasks that require regulatory and technical expertise:
We perform final model training using validated and regulation-compliant datasets, assess their performance together with the client, and ensure proper integration into the final product software.
Our experts translate clinical and functional requirements into robust software specifications, handle risk management, software verification, and ensure compliance with IEC 62304, ISO 14971, and – if needed – FDA regulations.
This creates an efficient division of labor:
Research and clinical questions remain with the client, while seleon ensures regulatory compliance and product maturity.
This coordinated collaboration makes it possible to bring innovation to market faster and more safely – in both Europe and the US.Â
Documentation & Post-Market Support
The entire development process is thoroughly documented:
Evidence of AI performance, risk analyses, and the results of verification and validation.
This documentation is essential for communication with authorities – and forms the basis for sustainable quality assurance.
Even after market launch, we remain actively involved.
Seleon supports the organization of all activities related to manufacturing, distribution, installation, market surveillance, and eventual decommissioning.
Our goal is always to deliver a product that is safe and reliable – throughout its entire life cycle.Â
Conclusion: Pioneering Progress Together
AI in medical technology is no longer a topic of the future – it is already reality.
But only those who combine innovative ideas with regulatory security and technical excellence can succeed in the market.
This is precisely where seleon comes in:
With experience, precision, and passion, we support our clients from research to successful product approval.
Let’s shape the future of medicine together. Get in touch – we look forward to your project!
