Kristiane Schmidt has joined Qserve as senior consultant where she is part of the IVD team. Due her more than 15 years of experience in IVD product development, her hands on experience with different technology platforms, her experience with technical files preparation as well as risk management activities she can perfectly support the IVD team.
Kristiane has more than 15 years of experience in IVD product development, ranging from proof-of-concept research to verification/validation and implementation of product development under ISO 13485. She worked in large multi-national corporations as well as small and medium sized companies.
She has a PhD in Biophysics and a master’s degree in biotechnology. With her extensive experience ranging from proof-of-concept studies to verification and validation, she can be of great significance to manufacturers of IVD devices.
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.
Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or auditing in medical devices. Check our current vacancies.