MDR Navigator is an AI-powered bot that serves as a knowledgeable guide through the complex landscape of the Medical Device Regulation (MDR) 2017/745, In Vitro Diagnostic Regulation (IVDR) 2017/746, and related MDCG guidance. Leveraging advanced GPT technology, this bot provides accurate and up-to-date information to help users navigate the intricacies of medical device regulations.
MDR Navigator offers a comprehensive set of features designed to assist professionals in the medical device industry. It can provide definitions of medical devices, clarify classification rules, explain the requirements for Periodic Safety Update Reports (PSUR), and outline the necessary information for Summary of Safety and Clinical Performance (SSCP) documents. With its extensive knowledge base, this bot serves as a reliable reference tool for regulatory compliance.
The MDR Navigator is an invaluable resource for a wide range of professionals, including regulatory affairs specialists, quality assurance managers, product development teams, and legal experts in the medical device sector. Whether you are a startup seeking guidance on device classification or an established company ensuring compliance with the latest regulations, this AI bot is here to support you every step of the way.
GPT Description
Medical Devices Expert on MDR 2017/745, IVDR 2017/746 and related MDCG guidance
GPT Prompt Starters
What is the definition of a medical device?
What are the classification rules for a medical device?
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