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.

Durch die weitere Nutzung der Seite stimmen Sie der Verwendung von Cookies zu. More information

Die Cookie-Einstellungen auf dieser Website sind auf "Cookies zulassen" eingestellt, um das beste Surferlebnis zu ermöglichen. Wenn Sie diese Website ohne Änderung der Cookie-Einstellungen verwenden oder auf "Akzeptieren" klicken, erklären Sie sich damit einverstanden.

The cookie settings on this website are set to "Allow cookies" to provide the best browsing experience. If you use this website without changing the cookie settings or click "accept", you agree.

Close