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QT Webinar: China Medical Device Registration

QT Webinar: China Medical Device Registration

  • 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.

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QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

  • 2021-06-24 02:55:03

We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing! Shall a CER be of interest for your business, please refer to the information within. Feel free to contact us for a first consulting session on this matter!

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USA: FDA Modifies List of Recognized Standards – June, 2021

USA: FDA Modifies List of Recognized Standards – June, 2021

  • 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

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