As of March 2016, Medicologic has strengthened the organization within Regulatory Affairs and Medical Device Development with a view to the company’s continued development and positive growth.
Randi Hauerberg came on board as Principal Advisor/Team Lead on March 1, 2016. Randi has more than 25 years’ experience within Regulatory Affairs, having submitted and obtained worldwide approval of numerous products within medical devices and in vitro diagnostics such as CE labeling according to MDD 93/42/EC, IVDD 98/79/EC, FDA 510(k) clearances and PMA approvals, Health Canada, CFDA, PMDA, KFDA, Brazil, Mexico, and Russia etc. For the last 5 and a half year she has worked as Regulatory Affairs Lead Manager for BK Medical ApS (Analogic Ultrasound).
Her many years of experience within Regulatory Affairs from manufacturers of medical devices and in vitro diagnostics combined with direct responsibility towards the authorities, contributes to her extensive knowledge about regulatory requirements worldwide in combination with obtaining regulatory approval with a focus upon speed to market and turnkey. Randi has also been appointed as Official Correspondent towards FDA and Health Canada and overall responsible for CE labeling.
She has previously held positions within Regulatory Affairs with Ferrosan A/S, Dako, Radiometer, PNN Medical, and BK Medical. Randi is also Chairman of the RA Expert Group outside EU, a member of the RA Expert Group within EU at Medicoindustrien. She has previously been a member of S-264 which is the Standardization Committee within IVD.
During her many years of experience she has contributed successfully to development projects, clinical, technical, marketing, sales and support, and approval of medical devices and in vitro diagnostics.