Qserve Group is pleased to announce that Thomas Ostermeier has joined our team to further expand its capabilities in supporting the medical device industries worldwide.
Thomas will be working as a Senior Consultant for the Qserve Group. As part of the Qserve German team, Thomas engages in various projects with DACH based clients but also supports European and Global projects. He has a wealth of regulatory, quality, clinical and development experience through many years in industry in the medical device field.
Before Qserve, Thomas started his professional career in the Automotive and Semiconductor industry as project manager for custom specific developments. With his move to Medical Device industry he worked as head of product development for almost ten years. His focus areas were product development, conformity assessments – mainly of sterile single-use products, and the quality management system.
He completed several product developments with his team, taking responsibility for the risk management, the fulfilment of international regulatory requirements, and the active communication with the Notified Body on product related questions. He provided strategic input on regulatory submissions, clinical evaluations, and support of complaint report determinations.
Thomas holds a Master of Science in Business Administration/Industrial Engineering – specializing in Mechanical Engineering. We are happy Thomas can bring this valuable experience into practice and sharing his knowledge. 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.