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About XportKat

Empowering HealthTech to Expand to New Markets and Validate MVP

Consider XportKat as a bridge between your team and goals to expand your HealthTech business worldwide. As your advisor, companion and reliable assistant in regulatory affairs (RA).

Xportkat's Smart Solutions provide a secure shield that protects Digital Health/HealthTech manufacturer expanding to the EU, US or Asia Pacific markets in the critical areas, as follows: 

  • Getting CE-Mark for medical devices of risk classes I - IIb in the EU or providing advice on FDA approval in USA to meet the requirements of the regulator 
     

  • Protecting against unfair competition
     

  • Proactive securing against feasible customers' claims.

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Empowering with RA-Solutions

Our portfolio of solutions includes, being not limited to:​
 

  • Engineering/development of Digital Health / HealthTech products
     

  • Implementing management systems to comply with the requirements of certification standards:  ISO13485, ISO27001, ISO27701, GDPR, HIPPA, etc.

  • Compliance with the requirements of regulators of markets in the EU, USA, Asian countries
     

  • Advice on selecting notified bodies (NB), European Authorized Representative in the EU
     

  • Search for partners and dealers in the EU, USA, or Asian countries
     

  • European Grant Programmes Solutions