Thomas Ostermeier

Thomas Ostermeier

Regulatory Expert


Introduction:

Since 2021, Thomas has been 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.

The key expertise areas of Thomas:

  • EU MDD / MDR
  • Risk Management
  • Building, upgrading and remediation of Quality Management Systems
  • Product Development
  • Technical File
  • Single-use devices
  • Reusable Instrument
  •  Internal Audits
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