Health Valley Event 2025

13 mrt 2025 | Nijmegen, Nederland

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Kobe Leysen

CEO & Founder

Extra Horizon

Hasselt, België

Deelnemer

Extra Horizon is a compliant cloud platform for cloud connected medical devices. Creating an easier and more cost effective go to market.

Organisatie

Extra Horizon

Extra Horizon

Bedrijf - ICT

Hasselt, België

Extra Horizon is a compliant cloud platform for cloud connected medical devices By using Extra Horizon’s platform, MedTech companies remove themselves from the need to build, certify and maintain a cloud platform and REST API’s themselves., We can speed up the time to market significantly as companies don’t need to build their solutions from scratch. Instead, they are relying on a hardened platform that undergoes regular penetration testing and auditing., Accelerate collaborations with hospitals and partners by using the Extra Horizon platform’s certificates as proof of compliance to the strictest levels of patient privacy and cybersecurity . (Extra Horizon Certification/adherence: ISO13485, IEC62304, ISO27001, ISO27701, HDH, HIPPAA, GDPR,…)., Companies building their digital solutions on Extra Horizon can benefit from the extensive privacy regulation accompanied with sensitive patient data. en Extra Horizon as extensive experience with building highly regulated digital products and can assist companies with the development and creation of products within healthcare and MedTech.
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Over

As a co-founder of fibricheck.com and as a Founder of extrahorizon.com I have over a decade of experience in bringing medical devices to the market. By leveraging our pre-certified platform we reduce risks and costs in bringing medical devices to the market.

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Vaardigheden

  • Cloud
  • Compliance
  • ISO134785
  • ISO13485
  • ISO27001
  • ISO27701
  • CE
  • FDA
  • Cybersecurity
  • HIPPAA
  • HDS
  • GDPR
  • MDR

Interesses

  • Medical device innovations
  • startups
  • Scaleups