Medical Device Manufacturers
Digitalize the validation of your medical devices and post-market surveillance activities quickly and cost-effectively
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Get ready for the EU MDR
The EU Medical Devices Regulation (EU MDR 2017/745) will come into effect as of May 2020. Avoid having your products taken off the market by working with a digitally connected and fully compliant solution for validating your medical devices. Save costs and accelerate time-to-market for your most innovative products.
By the way, here’s a free Whitepaper for you with a seven-point action plan that will support you in your PMS and PMCF preparation for the EU MDR.
Ensure Quality
Be prepared for new regulations and improve product quality by gathering and analyzing safety and performance data generated right at the source.
Save Time
Save up to 50% documentation time and 80% ramp-up time (based on Climedo research and references) compared to conventional methods.
Avoid Costs
Avoid costs and react faster to change requirements thanks to improved transparency in cases of non-conformance.
Key Features
Empower clients and patients with easy-to-use surveys, ePRO and eDiaries. Intuitive, drag & drop interfaces for structured, proactive data collection
Integrated reporting of (Serious) Adverse Events and incidents to notified bodies. Real-time data visualization and monitoring
Additional Features
Data point validation and quality checks
Hosting on multiple secure servers
Web-based eCRF system
Electronic signature
Electronic patient database and biosample database
Patient recruiting
Query creation and processing
Start your next clinical research project today
Fast
Smoothly and quickly transfer all your data points from previous systems. Convenient and with no need for prior data preparation or specialist IT skills.
Safe
Work in compliance with relevant regulations (GxP, EU MDR, IVDR, 21 CRF Part 11) and data protection laws according to German authorities.
Affordable
Our simple and flexible pricing model allows both commercial and non-commercial partners to benefit from the best solutions for their needs.
Climedo helps us to develop user friendly and professional solutions for quality assurance of complex therapies.
Prof. Dr. med. Lutz Uharek
Charité Berlin
Climedo Health shifts the data-driven approach into the focus of medical research and at the same time ensures data privacy.
Benjamin Bauer
Managing Director ZOLLHOF (Digital Health Hub)
With its innovative and user-centric platform, Climedo makes a decisive contribution to the new era of digital healthcare.
Andy Goldstein
Executive Director, LMU Entrepreneurship Center
