Birte Kappertz has been active in the health sciences sector since 2009. Since early 2020, she has supported clients worldwide as a qtec expert on regulatory topics such as QMS development, support for medical device development projects, successful global market approval of medical devices, and the duties and responsibilities of the Person Responsible for Regulatory Compliance (PRRC).
As a trainer at the qtec Academy, she educates medical device manufacturers on a wide range of topics including PRRC and Medical Device Coordinator (MPB) obligations, successful conformity assessment procedures, technical documentation preparation for medical devices and IVDs, market approval activities, and quality management system requirements under the MDR, IVDR, ISO 13485, and ISO 15189 / RiliBäk.
What matters most to her as a speaker: "Open dialogue, sharing knowledge, embracing challenges, tackling tasks as a team, and moving forward together. An interactive training day where everyone leaves with solutions, new impulses, and a bit wiser."
