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The responsibilities of the Pharmaceutical Affairs team include the identification and evaluation of risks and medical dangers as well the production of medical reports. They also bear responsibility for putting together clinical evaluation reports (CERs) and assisting with periodic safety update reports (PSURs).
Medical products are intensively monitored after being brought to market – information about device safety and performance is proactively collected, analyzed, and processed. Undesirable results are reported to the regulatory authorities. When necessary, team members provide support to the Corporate Safety Officer, including in the case of hearings held by the relevant authorities and in handling safety notifications and corrective measures.