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Larissa Schumann

+41 41 725 36 80
l.schumann@inmedis.ch
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Training

  • CAS Quality Management for Medical Devices, Lucerne University of Applied Science and Arts
  • Paper Technologist, Swiss Federal Certificate of Proficiency
  • Advanced training courses in quality management, risk management, auditing and computer system validation

Work experience

Larissa Schumann has been working in quality management since 2010 and has gained experience in the food, cosmetics, pharmaceutical and MedTech industries. During this time, she has held various roles in quality management and development.

She has been a Senior Consultant at inmedis AG since 2023. Prior to this, she worked for several years at Medela AG in various roles within quality and development.

Throughout her career, she has supported companies in setting-up and certifying management systems in accordance with ISO 13485, ISO 9001, MDR 2017/745 and 21 CFR Part 820. She has conducted audits, supported development projects through to CE and FDA approval, and prepared technical documentation and risk management files. She has also led projects in the areas of sterile packaging, process validation and computer system validation.

Specialist knowledge

  • Quality management systems and audits in accordance with ISO 13485, MDR and MDSAP
  • Technical documentation and risk management
  • Validation, sterile packaging and regulatory submissions
  • Project management in the MedTech industry
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