Medical Device companies meet the requirements of MDR

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The MDR – Medical Device Regulation – took full effect in May 2021 as an upgrade regulation to the existing Medical Device Directive, MDD. All medical devices developed must comply with the MDR as of May 2021.

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EasyTrial.net is your shortcut away from working with unstructured data collection, and data sharing on paper, in Excel sheets and via e-mails.

 

If you are involved in the development of medical devices you may benefit from carrying out your trials in an online management system that works across sites and borders and that assists in the structuring of your data collection and the sharing of data with all stakeholders.

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Use EasyTrial.net to administer the required evaluation of existing medical devices through post-market surveillance and post-market clinical follow-ups. Let EasyTrial.net become an integral part of your Quality Management System (QMS).

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Move your trial data and technical documentation into a closed and safe, digital management system that is accessible for all the stakeholders.

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In EasyTrial.net you can gather clinical evaluation data and real-world evidence such as:

• Post-market clinical trials

• Adverse events

• Customer surveys and user feedback

 

EasyTrial.net assists in structuring and documenting the entire development process:

• Preclinical studies

• Clinical studies

• Post design control

  • Patient empowerment (user feedback), complaints, new hazards, and deviations

  • Post-market surveillance (collection, documentation, and sharing of information about manufacturing and supply chain throughout the entire PLC).

  • Post-market clinical follow-up (clinical trials)

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