EnableChat - Your AI-powered MDR and MDCG chatbot

Dr Simon Cumiskey
Mantra Systems presents EnableChat, your AI-powered MDR & MDCG chatbot

A deep understanding of the MDR and associated MDCG documents is crucial for achieving compliance with the EU Medical Device Regulations.

However, the MDR itself is 175 pages long and the MDCG documents, at the time of writing, number over 100 files. With so much information available it can sometimes be difficult to find the relevant information.

To solve this problem we have developed EnableChat, your AI-powered regulatory chatbot.

About EnableChat - Your AI-powered MDR & MDCG chatbot

The Solution

EnableChat is, in simple terms, a question and answer service. Ask any question related to MDR compliance and, like magic, EnableChat will search the MDR and MDCG documents and find the answer you are looking for. It will even list the most relevant documents and provide a link, connecting you directly with them.

More specifically, EnableChat is a retrieval-augmented generative question and answering web application that finds the most relevant MDCG documents or MDR pages, before using a large language model to answer the user’s question based on the relevant documents. This method ensures high accuracy while maintaining a friendly, conversational style.

EnableChat is free to use (no sign-up required) and searches all the latest MDCG documents as well as the MDR text.

Try EnableChat

Related articles

  1. A precariously balanced pile of ping-pong balls and wooden bars.

    The Shift from MDD to MDR: Key Differences in Demonstrating Equivalence

    This transition has demanded that device safety must be demonstrated with more evidence. We offer tips for winning equivalence claims.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  2. A pen and notepad, resting on a laptop.

    Periodic Safety Update Report: Requirements under EU MDR

    Post-Market Surveillance has become more stringent. We help you to understand what manufacturers need to consider.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  3. An EU flag on a pole flies between two US flags against a blue sky.

    Webinar: From USA to Europe - Accelerating Your Path to the Medical Device Market

    We showed you how to quickly transform your U.S. regulatory work into a compliant EU MDR submission.

    Chandini Valiya Kizhakkeveetil Chandini Valiya Kizhakkeveetil Regulatory Medical Writer
  4. A poster frame for our Clinical Evaluation video series featuring Paul Hercock.

    Guide to Clinical Evaluation: Common Pitfalls & Useful Resources

    Part 5 - In the final video from this series, we explore five major pitfalls that often derail clinical evaluations.

    Dr Paul Hercock Dr Paul Hercock Chief Executive Officer
  5. A US-style 'changes ahead' warning road sign.

    Device Modifications: When a Simple Change Becomes a Regulatory Nightmare

    As regulatory consultants we understand how minor modifications to a device can often cause disproportionate disruption.

    Kamiya Crabtree Kamiya Crabtree Regulatory Medical Writer
  6. Webinar announcement poster.

    Webinar: Regulatory & Cybersecurity Essentials for medical device software and AI-enabled devices

    Our webinar with Cyber Alchemy addressed bringing AI-enabled medical devices to market with both the right regulatory and cybersecurity foundations.

    Shen May Khoo Shen May Khoo Regulatory Project Lead
  7. A simple jigsaw with iconography representing growth printed on it.

    Leveraging Post-Market Surveillance Data for Continuous Improvement

    PMS isn’t just about compliance, it’s an opportunity for improvement, enhance patient safety & innovate.

    Shen May Khoo Shen May Khoo Regulatory Project Lead
  8. A poster frame for our Clinical Evaluation video series featuring Dr. W. Brambley.

    Guide to Clinical Evaluation: CEP Strategy & CER Structure

    Part 4 - We explore how these guide reviewers through the evidence that supports safey, performance, and conformity.

    Dr Will Brambley Dr Will Brambley Lead Medical Writer
  9. A checklist being ticket-off in pen.

    The Critical Role of Pre-Submission Reviews in EU MDR Clinical Evaluations

    Ensuring your CER is robust and aligned with current standards is critical. How much Clinical Evidence is enough?

    Sandra Gopinath Sandra Gopinath Chief Regulatory Officer

More articles

Need help producing compliant CEPs & CERs? We are offering FREE CEPs to 5 qualifying applicants per week

Get your free CEP