The IMPALA Monitor Obtains CE Marking!

Our IMPALA Monitor is now CE marked!
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We're excited to share that our IMPALA Monitor has obtained CE marking, a big step forward as we work to bring IMPALA to more health workers, in more places, around the world.

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CE marking is the European Union's certification, granted under the new Medical Device Regulation (EU) 2017/745 (MDR), confirming that a product meets strict standards for safety, health, and performance. For medical equipment designed for intensive-care settings, like IMPALA, achieving Class IIb CE marking means passing a long and rigorous assessment built to prove reliability in real-world use.
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What it took to get here:

• Tens of quality tests
• Hundreds of pages of technical files
• Thousands of hours of work across our team
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What this means for GOAL 3:

• CE is widely recognized as a trusted quality standard around the world. Being CE marked makes it easier to secure local regulatory approvals in new markets, helping us scale IMPALA globally, faster.
• CE marking makes it easier for international partners to work with us. Many large institutional stakeholders only procure CE marked products, and the latest IMPALA Monitor can now meet that bar.
• IMPALA was designed for non-European settings from day one, but we've always aimed to meet the highest standard we could. Achieving CE marking is a strong validation of the quality and safety of our system.

We're incredibly proud that the latest IMPALA Monitor is now CE marked, and we can't wait to see the literal CE stamp of approval on IMPALA soon.