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.

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