AI-Powered First-Level Support for Regulated Medical Software – Coming Soon! Register now!

BAYOOMED has developed a tailored first-level support solution for medical software and digital health applications. Built with compliance and scalability in mind for regulated markets worldwide, this system supports companies operating in highly controlled environments.

We do not want to replace people. They act as the first point of contact from within the medical device. Instead, our approach is designed to optimize support processes while ensuring full traceability and professional control. It combines intelligent automation with expert validation and offers a solution that adapts to the needs of organizations in the healthcare and life sciences sector.

Here are the components:

At the heart of the solution is an integrated chatbot, embedded directly into the medical application. It serves as the first point of contact, offering multilingual support and consistent availability.

The chatbot is powered by a RAG-based model that performs semantic searches across a knowledge base articles, IFUs, additional manuals, support documentation, and regulatory content. Responses are relevant, contextual, and tailored to the user’s query.

If the system cannot generate a clear answer, fallback mechanisms such as escalation to the support team take effect. This ensures that users are never left without a solution.

Support requests are collected via email, in-app feedback, app store reviews, or chatbot transcripts. Each ticket is automatically translated into English and stored along with the original language, ensuring transparency and audit readiness.

The system categorizes the incoming tickets and generates automated response suggestions for all requests, with the exception of the chatbot. These are made available to the support team and checked by an employee before being sent to ensure accuracy and compliance with regulatory requirements. The chatbot, on the other hand, responds directly in real time based on the trained content and documents the entire process automatically.

Email or chatbot protocol

*Guaranteed review by the team: Answers from the ticket system are only sent after confirmation by the support team

BAYOOMED’s support solution also contributes to post-market surveillance efforts by structuring and documenting relevant interactions. Insights from this data are regularly shared during PMS meetings, helping our clients convert support signals into actionable regulatory insights.

Pharmacovigilance is seamlessly embedded in the process. The system flags PV-relevant cases for review, with reporting aligned to the client’s existing PV agreement such as those managed via BAYOOCARE. This ensures timely escalation and documentation of critical safety-related events.

BAYOOMED provides a customizable Power BI dashboard tailored to each client’s needs. Stakeholders can explore ticket activity through filters such as category, severity, status, and resolution time.

The dashboard visualizes recurring issues, emerging trends, and flagged PV content, supporting data-driven decisions and continuous quality improvements in both support and development teams.

BAYOOMED’s first-level support system is purpose-built for the life sciences and digital health sectors. This solution not only enables compliance. It reduces operational burden. By automating routine tasks while retaining expert control where needed, companies can scale their support capabilities while significantly reducing cost and time spent on manual processes.

The system is not just a tool for user communication. It is a regulatory asset that helps health tech innovators meet their obligations, improve service quality, and remain inspection-ready.

The AI-powered first-level support solution will be available at the beginning of Q4 2025. BAYOOMED is already working with selected partners to prepare for rollout.

Chatbots for additional use cases such as patient onboarding, study engagement, or digital therapeutics are available upon request.

Interested companies can contact us directly using the contact form below. We look forward to supporting your digital health innovation.

A key advantage of the BAYOOMED support solution is its combination of flexibility, technological progress and strict data protection compliance. New knowledge bases can be trained and updated in less than an hour, enabling rapid adaptation to new content or products. The underlying language model (LLM) is exclusively hosted locally – there are no connections to OpenAI or external cloud AI interfaces. This means that all data remains completely private and is not used for training purposes. Thanks to the modular design, regular updates to LLM and the RAG framework ensure that the solution always remains technically up to date. Companies not only benefit from a noticeable increase in efficiency and cost reduction in first-level support, but also from a solution that meets the highest data protection and regulatory security requirements.