About Me
14 years of experience as Project Manager of several successful, innovative medical device delivery at Brainlab Ag. I can manage all the aspects of a project including planning, strategy, coordinate development, implementation and assessment in compliance with IEC Standards, CB Reports and System Design, which includes collateral (60601-1-X) and particular standards (60601-2-X) as well as documentation of functional safety. This includes preparing documentation for CB Reports, technical file audits (MDR) and passing 510k submissions. As internal certified supplier auditor, ensuring that the project deliverables match the objectives of the organization and the company’s QM system in a timely manner.
