Lloyd Gaedke - Senior Consultant, Quality & Regulatory Affairs

Lloyd Gaedke brings more than 30 years of In Vitro Diagnostics (IVD) and medical device experience to Emergo and applies his knowledge of this industry to address the needs of Emergo's IVD and medical device clients worldwide. His vast expertise managing regulatory affairs, quality and development projects in both the US and European markets gives Lloyd an understanding of the technical and regulatory compliance issues facing manufacturers.

Lloyd  is actively involved in preparing Technical Files, US FDA  applications and Investigational Device Exemption (IDE) submissions. His knowledge of the OSHA and CLIA regulations in clinical environments and corresponding US, European and other international quality assurance and regulatory requirements also makes him an invaluable asset to IVD clients.