01 · Profile

Torsten
Kneuss

Medical Devices · Combination Products · Pharma

30+ years · PRRC (MDR 2017/745) · ISO 14971 · DE / EN

Quality, compliance, and innovation where pharmaceuticals, devices, and technology meet. Advising teams from first concept through post-market life.

About Me Get in Touch

02 · Practice

Three disciplines,
one quality mindset

Depth across devices, packaging, and digital quality in regulated industries.

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.

03 · Current