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01 · About

Torsten Kneuss

Quality, compliance, and innovation for medical devices and combination products.

30+ years in Pharma & MedTech · PRRC (MDR 2017/745) · ISO 14971 · 4 core certifications · German & English

Introduction

Hello! I'm Torsten Kneuss. My journey into the pharmaceutical industry began early, driven by a fascination with using science to aid patients, particularly those battling serious illnesses. The diverse and international nature of the pharmaceutical business, with its myriad sites and varied people, has always held a strong appeal for me.

My professional career commenced with an apprenticeship as a pharmaceutical production technician. This early introduction to the field was followed by several years of dedicated work, which sparked my interest in further education. I decided to pursue a part-time study in Business Administration and Engineering in Berlin.

Since then, I've amassed over 30 years of experience in the pharmaceutical industry, focusing on medical devices (including medical software), (drug/device) combination products, pharmaceutical packaging, and information technologies. A significant portion of my work involves project management, especially within an international environment.

Career Milestones

  • Development and launch of a large-volume pre-filled plastic syringe
  • Creation of an RFID-based solution for tracking contrast media syringe usage
  • Debut of an innovative autoinjector
  • Introduction of the first Medical Software within a Pharma business unit
  • Leading a Quality unit for Medical Devices & Combination Products with emphasis on Risk Management and Design & Development oversight

Certifications & Training

Risk Management for Medical Devices (ISO 14971)
Quality Management (ISO 9001 and ISO 13485)
Auditor Training (ISO 13485)
Certified Professional for Medical Software

Community Involvement

  • Supports an association promoting childcare in his village
  • Contributes to the EFPIA working group for Drug Device Combinations
  • Member of the DIN committee for Quality Management of Devices

Interests & Values

  • Family, boating, and gardening
  • Information Technology & programming (Python, Docker, Cloud)
  • New Work philosophy (Frithjof Bergmann): modern collaboration & diversity
  • Continuous learning and leadership development

Interested in working together or inviting me to speak at your event?

Get in Touch