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Local experts. Global reach since 1980

We are MEDISI, we were the first Mexican consultancy company specialized in Medical Devices and now we are the best consolidator for regulation in Latin America and USA.

Our main value proposal is excellence at affordable, ethical rates that can make you our long time partner. We understand your international GMP language and we help you translate it into each local market with timely and business oriented solutions.

LATEST NEWS

COFEPRIS Evolves

COFEPRIS Challenges 2020

Since December 1st, 2018 a historical change in administration that consisted of a new president who is committed to Public Office cleansing of corrupt and unequal practices had a strong impact on the whole country course of operation. Many institutions were eliminated or were audited and restructured.  Cofepris was audited and analyzed for permanence or …

ResMed ventilators recall is Class I

FDA today designated a ResMed (NYSE:RMD) recall of certain Stellar non-invasive and invasive ventilators as Class I — the agency’s most serious level. The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, or powers on automatically when connected …

Finding a non-invasive way to predict effectiveness of cancer therapy.

«Researchers have taken a critical step toward developing a non-invasive nuclear medicine technique that can predict the effectiveness of therapy for cancerous tumors, allowing for personalized, precision treatment.» Read more.  

Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices

«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each …

Researchers produce first laser ultrasound images of humans.

«Engineers have come up with an alternative to conventional ultrasound that doesn’t require contact with the body to see inside a patient. The new laser ultrasound technique leverages an eye- and skin-safe laser system to remotely image the inside of a person.»   Read more