MDSAP certificate for electrophysiology system

The medical-technology company fulfils another requirement for international success

Schwarzer Cardiotek’s electrophysiology system EP-TRACER is used in cath labs worldwide. Catalyzed by the distribution agreement with Medtronic success in international sales projects continues. The MDSAP certificate, which CardioTek B.V. received yesterday, further strengthens the international business. Within the MDSAP, Medical Device Single Audit Program, different regulatory authorities cooperate internationally, to examine all regulatory requirements within one audit. For manufacturers like Schwarzer Cardiotek the certificate simplifies the market entry within the participating countries. The MDSAP certificate supports the registration of EP-TRACER 2 in Brazil. Also for distribution in the USA the certificate is helpful in addition to the FDA clearance. The company received the FDA clearance for the recent software version 2.2 at the beginning of the year.

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