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Lutz Stehling

Training

  • MSc in Mechanical Engineering, University of Kassel
  • Advanced training courses in packaging integrity, regulatory affairs and process validation, including courses with TÜV Süd and SAQ Qualicon

Work experience

Lutz Stehling has been working in MedTech since 2002. He initially worked as a development engineer, project manager and director of business development at companies such as Boston Scientific, Biotronik, Flex and Zimmer Biomet.

He has been a Senior Consultant at inmedis AG since 2016. During this time, he has supported numerous client projects, including the development of medical devices through to CE marking, the implementation of process validation, and support for packaging development and packaging integrity.

His areas of expertise lie in risk and quality management, process validation, and packaging systems for sterile medical devices.

Specialist knowledge

  • Regulatory Affairs and MDR 2017/745
  • Packaging systems and packaging integrity for sterile medical devices
  • Quality management systems in accordance with ISO 13485 and GMP
  • Risk management
  • Process validation