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Balanstraße 71a, 81541 Munich, Germany
If you're in Munich, stop by our office on Balanstraße, right next to Meta and Accenture. Come work from our desks for a day and see what we're building.
Frequently asked questions.
How long does it take to get started?
We look at your fleet and your workflows first, then scope a pilot of around 200 to 500 devices. From kickoff to live is usually 6 to 12 weeks, including tagging the devices and rolling out to the teams that will use them. What moves the timeline is mostly fleet size and how much device data you already have.
How does sqanit fit into our MDR obligations?
It covers two specific things.
Electronic instructions for use: Regulation (EU) 2021/2226 lets you supply the IFU electronically for professional-use devices, as long as the label points users to it and you can still send a paper copy within seven days. The code on the device is that pointer, and it opens the version tied to that serial number instead of a model list somebody has to search through.
Post-market surveillance: every service case is recorded against the serial number, so the history is already there when MDR Article 83 reporting asks for it.
What stays with you is the risk assessment that decides whether a device qualifies for eIFU, and your quality management system. sqanit supplies the record and the delivery channel. The conformity decision is yours.
Does sqanit require an app or login for end users?
No. Users scan the QR code with their phone camera and land directly on the device information or the service flow. There is no app to download and no account for the end user. The device itself does not need a network connection either, because the record is updated by the people scanning it and by the systems you already run.
How does sqanit work with the systems we already use?
sqanit is API-first and designed to work alongside your existing systems. Device records and service data can be exchanged through REST APIs and connected to systems such as ERP, CRM, service or asset-management platforms.
sqanit also supports GS1 and UDI standards and is a GS1 Germany Solution Partner, so existing device identifiers can be used rather than creating a separate identification structure.
Is sqanit secure and compliant?
sqanit creates a traceable record of device and service interactions at serial-number level, helping teams maintain the documentation needed for regulated service and quality processes.
The platform is hosted in the EU and designed in line with GDPR requirements. Access and permissions can also be managed based on user roles and responsibilities.