AI-Powered Clinical Research Simplified
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EPI MDR
The EPI MDR module is designed to assist researchers, manufacturers, and regulatory professionals in navigating the intricate requirements of the Medical Device Regulation (MDR) framework. As a specialized GPT-powered assistant, Epi provides insights, guidance, and practical tools for ensuring that medical devices meet rigorous safety and performance standards. From initial regulatory assessments to ongoing compliance, EPI MDR is your reliable partner in achieving and maintaining MDR certification.
MDR compliance is critical for market access and device credibility within the European Union. EPI MDR simplifies the complex documentation, submission processes, and post-market surveillance activities, ensuring your products are compliant and safe for users. With step-by-step guidance, expert insights, and personalized support, this module empowers you to stay ahead in the ever-evolving regulatory landscape.
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Regulatory Documentation Guidance: Epi assists with creating and organizing the documentation required for MDR submissions, ensuring that all necessary components are complete and up to standard.
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Clinical Evaluation Support: Navigate MDR’s clinical evaluation requirements with support for conducting literature reviews, assembling clinical data, and ensuring regulatory compliance.
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Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF): Keep track of device performance and safety post-approval with structured PMS and PMCF processes, critical for ongoing MDR compliance.
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Ethics Committee and Regulatory Pathways: Understand the ethical and regulatory pathways specific to your device, with guidance on selecting appropriate committees and fulfilling legal requirements.
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Risk Management and Quality Assurance: EPI MDR offers tools to manage risk assessment, quality assurance processes, and address any issues that arise in real-time, ensuring safety and regulatory compliance at every step.
"Hello and welcome to EPI MDR GPT! I’m Epi, your dedicated AI assistant for navigating the complex world of Medical Device Regulations. As part of EPI MDR GPT, I’m here to provide you with personalized support, guidance, and insights to simplify MDR compliance. From documentation to clinical evaluations, together, we’ll ensure that your medical devices meet the highest standards of safety and performance."
"With EPI MDR GPT, you’ll have step-by-step assistance through regulatory submissions, post-market monitoring, and risk management. Let’s make the MDR process smooth, efficient, and aligned with your compliance goals!"
"Wishing you success on your regulatory journey! With EPI MDR GPT by your side, you’ll be fully prepared for every aspect of compliance. Let’s set new standards for quality and safety in medical devices together!"
Packages
Accelerate your clinical research with E-PICOS packages tailored to meet your needs. From MyData to advanced statistical calculations, AI-powered study designs to ethics management, our modules support every stage of your research. Explore our flexible package options or purchase the Meta module separately for additional insights.
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Is E-PICOS only suitable for specific research fields?E-PICOS is suitable for both clinical and academic research across various disciplines, offering tools for statistical analysis, ethics, and more.
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Do I have to purchase all modules as a single package?No, you can purchase individual modules based on your needs. However, we also offer cost-effective package options.
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Are E-PICOS's AI-powered modules difficult to use?E-PICOS’s AI-powered modules are designed for ease of use, guiding researchers through study design, analysis, and ethical processes seamlessly.
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Is E-PICOS only available in English?While the software is primarily in English, our website and user guides are available in 10 languages: English, Turkish, Spanish, French, German, Chinese (Simplified), Russian, Portuguese, Arabic, and Japanese.
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Is there no support available within the E-PICOS platform?E-PICOS offers extensive support through live help, AI avatars, and a range of resources including tutorials and documentation.
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Are my data unprotected in E-PICOS?E-PICOS ensures the highest level of data security with encryption and restricted access to authorized users only.
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Does E-PICOS offer a free trial version?No, E-PICOS does not currently offer a free trial version, but we provide various modules and packages at affordable prices.