Biocompatibility Specialist
Mühlheim An Der Donau, Baden-Württemberg, Germany
+ Implementation of ISO 10993 to assess risk-based biological safety of medical devices, especially surgical instruments and implants by (systematic) literature review, preparation of biological evaluation plan, writing biological evaluation report, to ensure timely compliance with regulatory requirements (FDA, MDR (EU) 2017/745)+ Selection, planning, commissioning and monitoring of testing at external laboratories, institutes and experts by developing scientifically creative efficient… Show more + Implementation of ISO 10993 to assess risk-based biological safety of medical devices, especially surgical instruments and implants by (systematic) literature review, preparation of biological evaluation plan, writing biological evaluation report, to ensure timely compliance with regulatory requirements (FDA, MDR (EU) 2017/745)+ Selection, planning, commissioning and monitoring of testing at external laboratories, institutes and experts by developing scientifically creative efficient solutions to meet deadlines+ Support project manager, developer, and regulatory affairs on biocompatibility issues during product design review and process validation by identifying biological risks and ensuring appropriate objective evidence for acceptance criteria+ Successful biological Evaluations that lead to 510(k) FDA, MDR clearance for titanium and PEEK implants+ Development of SOP for Biological Evaluation+ Support in Validation for final in-process cleaning and Validation for reprocessing Show less