Dr. Michael Diechtierow

People Leader and Subject Matter Expert in R&D Point of Care. Responsibilities include topics such as Risk Management (ISO 14971, Design for Quality), Submission and development documentation (IVDR, FDA, NMPA, CLSI) and process implementation (ISO 13485, ISO 9001).

- Responsible for Product Risk Management acc. to ISO 14971 (incl. e.g. CLIA requirements and Usability Engineering) - Responsible for planning and documentation of international Verification Studies according to e.g. CLSI, FDA, CFDA, DIN, ISO - participation and point of contact to external expert networks and committees (CLSI, DIN, ISO) - Responsible for compliant development documentation (DHF/DDF) - Design for Quality & Manufacturability, Process Risk Management - Quality representative for R&D PoC

- Responsible for Product Risk Management acc. to ISO 14971 (incl. e.g. CLIA requirements and Usability Engineering) - Responsible for planning and documentation of international Verification Studies according to e.g. CLSI, FDA, CFDA, DIN, ISO - participation and point of contact to external expert networks and committees (CLSI, DIN, ISO) - Responsible for compliant development documentation (DHF/DDF) - Design for Quality & Manufacturability, Process Risk Management - Quality representative for R&D PoC

- Implementation, control and continuous improvement of QMS stipulations (ISO 13485/QSReg) - Generation and review of Quality Management System stipulations (QAPs/SOPs) - Understanding process landscapes - Fusion of QM Systems - SOP generation - Document Management - Internal Auditing - CAPAs - Audits

- Deviation Management - CAPAs - SOP generation - Moderation and Documentation of Product Problem Meetings

In vivo and in vitro characterization of trypanosomic redox enzymes