Torsten
Kneuss

Medical Devices · Combination Products · Pharma

Quality, Compliance and Innovation for Medical Devices and Combination Products. Nearly three decades at the intersection of pharmaceuticals, devices, and technology.

About Me Get in Touch

What I do

Specializing in Design Controls, Risk Management (ISO 14971), and Post-Market Surveillance. Expertise across the full product lifecycle — from early development through regulatory approval. Person Responsible for Regulatory Compliance (PRRC) for Combination Products under MDR 2017/745.

Risk Management per ISO 14971
Design & Development oversight
Vigilance and PMCF
MDR / IVDR compliance
PRRC responsibilities

More than 25 years of hands-on experience with pharmaceutical packaging materials, from development through Quality Control. Deep knowledge of global regulatory requirements and functional testing methodologies for primary and secondary packaging.

Container closure integrity
Pre-filled syringe development
Packaging materials qualification
Global regulatory requirements
Drug-device primary packaging

Combining software development, database management, and IT security with modern AI capabilities. Focus on safe and compliant adoption of AI in Pharma and Medical Devices — enabling smarter decisions and higher quality outcomes in regulated environments.

AI-assisted quality processes
Automated documentation workflows
Data analytics in regulated environments
Python, databases, Docker, cloud
IT security for medical software

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.