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.
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.