Quality. Compliance. Impact.

Torsten Kneuss

Quality, Compliance and Innovation for Medical Devices and Combination Products

Torsten Kneuss
Professional Background

About Me

With nearly three decades of experience at the intersection of pharmaceuticals, medical devices, and technology, I help organizations develop safe, compliant, and patient-centered products. My work spans the entire lifecycle — from early development to regulatory approval and post-market surveillance.

I have held roles in R&D, Quality Control, Quality Assurance, Operations, and Vigilance. This broad perspective enables me not only to interpret regulatory requirements, but to translate them into practical, effective, and sustainable solutions.

Today, I lead a Quality organization for Combination Products and serve as a Person Responsible for Regulatory Compliance (PRRC). Operating at the interface of engineering, quality, and regulation, I am committed to ensuring that products meet the highest standards of safety and performance.

I also bring strong technical expertise in software development, data management, and IT security. This blend of domain knowledge and digital capability allows me to evaluate modern technologies quickly and integrate them meaningfully into quality and compliance processes.

Quality, for me, is more than a requirement — it is a mindset. It begins with the first idea for a product and continues throughout its lifecycle, always with one objective in mind: improving outcomes for patients.

Core Expertise

What I Do

Medical Devices & Combination Products

Specializing in Design Controls, Risk Management, and Post-Market Surveillance. Expertise in Vigilance and Regulatory Compliance, ensuring safe, robust, and patient-oriented product development.

Pharmaceutical Packaging

Comprehensive experience from Development to Quality Control. More than 25 years of hands-on work with packaging materials, functional testing, and global regulatory requirements.

Digital Quality, Data & AI

Combining software development (Python), database management, and IT security with modern AI capabilities. Experience with AI-assisted quality processes, automated documentation workflows, data analytics, and digitalization in regulated environments.

Focus on the safe and compliant adoption of AI technologies in Pharma, Medical Devices, and Combination Products — enabling smarter decisions, improved process efficiency, and higher quality outcomes.

Insights & Updates

Latest News & Articles

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Breaking Boundaries: Exploring the World of Combination Products
Combination Products

Breaking Boundaries: Exploring the World of Combination Products

Explore the innovative world of combination products. Discover new possibilities in healthcare.

Audit Checklist for Risk Management as per ISO 14971 (generated by ChatGPT)
Medical Devices

Audit Checklist for Risk Management as per ISO 14971 (generated by ChatGPT)

This article provides an audit checklist for evaluating the risk management process according to ISO 14971. ChatGPT prepared the checklist.

Regulating Health: The Impact of the European Medical Device Regulation on Medical Device Availability
Medical Devices

Regulating Health: The Impact of the European Medical Device Regulation on Medical Device Availability

Understand the EU Medical Device Regulation's impact on availability. Stay informed now.