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October 10, 2018

A new outlook for the Medical Device industry: Shanghai releases 100 initiatives for economy expansion

Shanghai’s 100 opening-up measures unveiled on the 10th of July sent a jolt of excitement to both foreign and domestic industry leaders. Shanghai, well-known the financial center of China, is aiming to improve its service and manufacturing industries.
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October 10, 2018

5 practical ways to streamline your IT system validation

Validation of IT systems is a requirement by both the FDA 21 CFR QSR regulations and the ISO 13485 standard. The 2016 version of this ISO standard has been aligned with QSR and extends the validation scope with IT systems used in the Quality Management System, such as training, CAPA, and complaint handling systems. 
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October 02, 2018

Interview with Stefan Menzl: MedTech Training Program 2018-2019 (part 2)

Qserve offers medical device manufacturers training at all regulatory, quality, and clinical levels. As a global medical device consultancy with offices in Europe, the United States and China, Qserve's staff offers years of international experience, with both broad and specific expertise for a wide range of medical devices and IVD's. In this interview, we highlighted several questions for Stefan Menzl, Executive Director of Qserve Group Deutschland GmbH.  
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October 01, 2018

Webinar MDSAP German

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October 01, 2018

Webinar EU-MDR German

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