Archive for August, 2016

We strengthen Regulatory/QA capabilities by hiring Gert Nielsen

As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Gert Nielsen in the role as Senior Regulatory Affairs Consultant.

Gert NielsenGert has almost 20 years of experience within Regulatory Affairs, working for a number of med-tech companies including Ambu, Radiometer and GE Medical Systems. Lately, he worked four and a half years for ultrasound equipment manufacturer BK Medical. At Medicologic Gert’s primary responsibility will be to support clients by developing classification and mapping of regulatory strategies, creating technical files and design history files as well as preparation and submissions of FDA 510(k) and international applications. Gert will also be working as a QP (Qualified Person) for selected clients.

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