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After creating an account, you’ll be taken to your device library. Here, you can add your medical device and start the documentation process. You have two ways to add your device:

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Importing Your Device with AI

Enter the URL of a webpage with a detailed description of your medical device. Our AI will automatically extract relevant information and pre-fill the form for you.

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Filling in Your Device Manually

Manually enter the required information, including:
  • Device Name: The official name of your device.
  • Device Description: Provide a comprehensive description. Our AI uses this to help generate documentation, so detail and length is key.
  • Relevant Regulations: Specify the target markets. Selling in the US requires FDA compliance, while the EU requires compliance with regulations like MDR or IVDR for CE marking.
If your device processes human samples, it’s an In Vitro Diagnostic (IVD) medical device and falls under the EU’s IVDR.

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Hardware Components

Examples of hardware components would be a smart-watch or a pacemaker
If your medical device includes physical components, you’ll need to describe each one separately. Physical components are closed systems which typically combine hardware, firmware, and potentially embedded software. For multiple components, repeat this process for each part. To evaluate the scope of physical documentation and testing requirements needed, answer the following questions:
  • Is sterilization required?
  • Does it come into contact with the human body?
  • Is it implantable?
  • Does it contain mechanical parts?
  • Does it contain electrical parts?
  • Does it contain firmware?
  • Does it contain software?
Each hardware component’s characteristics directly impact specific regulatory requirements and documentation.

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Standalone Software

If your medical device includes standalone, in-house developed software, you’ll need to enter its name and provide a description. This is only about standalone software and not about software that is part of the device. The presence of AI capabilities will also influence your regulatory classification and documentation requirements under medical device regulations.
You also have the option of adding multiple software components, which could be helpful for independent releases and updates.

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Editing Your Device

To edit your device characteristics after creation, open the Roadmap and click the pencil icon right next to the device name. After editing, click the update buttom at the bottom of the page to save your changes.
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