QualitiBot • AI Agent

QualitiBot is an agent based on language models (LLM), integrated into a traditional software application. It is designed to support professionals in the medical devices sector in Europe.

For any questions, feel free to log in and consult the ℹ️ Information section of QualitiBot.

Knowledge

Regulations : Regulation (EU) 2017/745 (MDR) and other European texts.

Standards : ISO, IEC, CEN/CENELEC applicable to medical devices.

Guides and best practices: : MDCG publications, official recommendations, Qualitiso documents.

Key Skills

Inform: Provide explanations on regulations, standards, and quality processes..

Assist: Help implement responses to requirements..

Analyze: Evaluate compliance, device qualification, and risk management.

Advice: Suggest strategies for CE marking , audit, document management…

Research: Access up-to-date information via the internet and specialized news feeds.

Create: Generate exportable documents (.doc)

Available ressources

General knowledge : Language models (LLM).

Specialized knowledge bases: ISO requirements, MDCG guides, lists of standards, standard procedures, etc.

News feeds: Daily regulatory and standards updates.

Internet : Real-time search.

Examples of queries

What is the definition of MD?

What is the risk class of a chair with a weighing function?

What are the latest regulatory developments concerning AI?

Compare the rates of French notified bodies.

My device is an ECG: 1. list the applicable standards 2. create a table responding to the general requirements of the MDR.

Write a blog article summarizing the PIP case, using the internet to find information.

Write a risk management procedure, taking into account the RDM, ISO 14971, and XP S99-223 (max. 12 sections).

JI have provided my clinical evaluation procedure and the list of non-conformities: draw up an action plan to resolve these non-conformities.

Access & Subscriptions

The data used by the bot varies depending on your subscription :