Andreas Sewing

Responsible for the department Scientific Services: - Biological and clinical evaluation of medical devices and combination products for international registration processes and within developmental projects. - Planning and execution of clinical studies to prove the safety and performance of PMMA based bone cements, bone substitutes and local antibiotic carrier. Post market surveillance and post market clinical follow-up for the product portfolio. - Responsible for the contact to scientific community and institutions.

Evaluation of different antimicrobial technologies (antibiotics, antisepics, antimicrobial peptides, silver, etc.) for the coating of orthopedic implant. Managing of international interdisciplinary project teams: - Evaluation and takeover of the antimicrobial coating technologies from companies, start-ups or university working groups. - Setup of a device capable for a campaign production in the USA and implementation of characterization methods (HPLC, microbiological tests) in Berlin. - Work on a concept for a registration strategy within the international project team: risk analysis, biocompatibility, preclinical and clinical studies. - Support of the registration process for combination products by active participation in the consultation process at BfArM and the Japanese PMDA. - Project planning and documentation according to quality management requirements, Design Control and reporting. Planning and control of the project budget.

Project manager for different project in the field of bone substitutes, biomineralization and coating technology to improve the tissue integration and antimicrobial activity of orthopedic implants. E.g. the BoneMaster calcium phosphate coating: establishing of a production process with the corresponding QM documentation and QC methods; Process validation; Writing of the Design Dossier. Support of the implementation of the BoneMaster production processes at subs in Spain, k and USA; Training of the staff. Support of the marketing by presentations at conferences and Biomet events. Support of the 510(k) registration in the USA.

Writing of applications for public funded projects and responsibility for the contacts to project partners, centers of excellence and the BMBF, project and budget planning, reporting. Transfer of the results into internal developmental projects. BMBF-project: Bio mineralization of collagen I und collagen I assemblats. BMBF-project: Tissue design with functionalized molded bodies of collagen and mineralized collagen for surgical applications. BMBF-project: Preparation of 3dimesional biomimetic layer structures on surfaces of implants of titanium base alloys with partners from TU Dresden and Göttingen University.

Research associate at the Institute for Material Science at TU Dresden within the DFG focus program High temperature corrosion: Electron microscopic analysis and theoretical modelling of the high temperature corrosion of intermetal-lic compounds.

Wissenschaftlicher Mitarbeiter der Max-Planck-Gesellschaft in der Arbeitsgruppe ‚Mechanik heterogener Festkörper‘ der Max-Planck-Gesellschaft an der TU Dresden auf dem BMBF-Projekt: Preparation of nm-scale multilayers with new physical properties by laser pulses in the nano and pico second range

Research associate at Max-Planck-Society in the working group ‚Mechanics of heterogeneous solids‘ of the Max-Planck-Society at the TU Dresden within the BMBF-project: Preparation of nm-scale multilayers with new physical properties by laser pulses in the nano and pico second range. PhD student at TU Dresden on the subject: Preparation of Ni-C multilayer and mixed systems with a two beam PLD method and evaluation of the thermal stability of the layer systems.

Minor: Biophysics Diploma thesis at HASYLAB with the title: Preparation and characterization of thin layers of Bi2Sr2CaCu2O8+x and photoe-mission spectroscopy at the Ge/Bi2Sr2CaCu2O8+x interface

AKAD-seminar of the incentive program for junior employees of the Merck KGaA: Business administration and marketing for non-business people