evolution duo: compatibility with Philips Azurion confirmed
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 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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Schwarzer Cardiotek introduces software version 2.2 for the electrophysiological measuring system EP-TRACER.
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