medical device manufacturer

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 new EU-MDR

The new EU Medical Devices Regulation (EU MDR) 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 Infographic for you with five steps that will support you in your preparation for the new 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

epro patient ediary

Integrated reporting of (Serious) Adverse Events and incidents to notified bodies

Real-time data visualization and monitoring

serious-adverse-events1

Additional Features

  • Data point validation and quality checks
  • Web-based eCRF system
  • Electronic patient database and biosample database
  • Query creation and processing
  • Hosting on multiple secure servers
  • Electronic signature
  • Patient recruiting

Start your next clinical research project today

fast-moving

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