MIPM continues to expand worldwide

After around 3.5 years of intensive work, MIPM (Mammendorfer Institute for Physics and Medicine GmbH) has achieved an unprecedented success with the approval of the TeslaDuo patient monitor in China: the institute can now operate there with almost no competitors. The MIPM family breathes a sigh of relief, also because the approval process in China was very challenging. The TeslaDuo, like the TeslaM3 patient monitor, is already recognized and approved by independent international testing institutes. However, China has its own standards. Andreas Klement, Vice President at MIPM, answered open questions from a CFDA (China Food and Drug Administration) inspector on-site in China at the beginning of the year. The authority is responsible for the approval of medical technology products, including the patient monitors developed and produced by MIPM. The monitors reliably measure patients' vital functions during MRI examinations. MIPM's expertise is evidently well-received in China, as 22 TeslaDuo monitors have already been ordered for the Middle Kingdom.

A personal success for Eva Anderton is the registration of the TeslaDuo in Italy. "As a re-entrant into the workforce, Eva initially had other tasks. However, she developed so well that we quickly entrusted her with a larger area of responsibility, namely the registration of our products in other countries," explains Jennifer Rosenheimer, junior manager at MIPM. The institute is constantly looking for new employees, "and re-entrants are warmly welcome," emphasizes Jennifer Rosenheimer.

Italy, as an EU member, is the only country in the Union that requires extensive registration of medical products. This registration is controversial among member states as it violates the free movement of goods within the Union and has already led to lawsuits. "A valuable help in the complex registration process was the German-Italian Chamber of Commerce (AHK) in Milan," reports Eva Anderton.

Nevertheless, the registration of the TeslaDuo was delayed because a renewed CE certificate was missing. The certification company Notified Body SGS UK was supposed to take care of this. "Due to massive organizational problems at SGS, there were repeated delays. Only under significant pressure from our side did we finally receive a renewed certificate," says Eva Anderton.