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:
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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
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Protecting against unfair competition
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Proactive securing against feasible customers' claims.
Empowering with RA-Solutions
Our portfolio of solutions includes, being not limited to:
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Engineering/development of Digital Health / HealthTech products
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Implementing management systems to comply with the requirements of certification standards: ISO13485, ISO27001, ISO27701, GDPR, HIPPA, etc.
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Compliance with the requirements of regulators of markets in the EU, USA, Asian countries
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Advice on selecting notified bodies (NB), European Authorized Representative in the EU
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Search for partners and dealers in the EU, USA, or Asian countries
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European Grant Programmes Solutions