Our team of skilled regulatory & certification, SaMD and AI experts:
Univ. Doz. (ETH)
Dietmar Schaffarczyk
Dipl. Lead Auditor
Lead Technical Assessor
Medical Writer
Regulatory & Compliance Strategist
A dynamic force in the HealthTech sector, serving as Lecturer at ETH Zurich, specializing in Regulatory Thinking and Certification Strategies, and a Scientific Associate at D-HEST ETH Zurich, driving advancements in AI for HealthTech and Regulatory Affairs.
Award-winning CEO, keynote speaker, and editor, recognized for transformative contributions to the medical device and biotech industries.
“With extensive experience in regulatory affairs and certification, I’ve helped pioneer solutions that bridge innovation and compliance.”
Latest Publication:
Applied Body-Fluid Analysis by Wearable Devices.
Nature, Dec 2024, 636(8041):57-68.
DOI: 10.1038/s41586-024-08249-4
“Let’s shape the future of HealthTech together.”
Niko Mangold, B.SC.
Lead Auditor
TechFile Specialist
Software PLC Expert
Smart Systems Developer
“As an accomplished trainer and auditor in regulatory standards, I focus on internationalization, helping organizations navigate global compliance landscapes with confidence. As a strategic thinker, I empower startups, mid-sized companies, and corporations to align innovation with regulatory excellence, driving sustainable growth and global success.”
Specializing in AI-driven SaMD solutions for the healthcare sector and advancing AI in regulatory frameworks, Niko brings cutting-edge expertise to the intersection of innovation and compliance.
“Let’s innovate smarter and lead the future of healthcare together.”
Claudia Pavel, PRRC
QMS Senior Expert
Document Control Expert
Process Implementer
Efficiency Architect
Navigating life’s intricate fabric, Claudia Pavel harnesses her expertise as a QMS Senior Expert and Quality Systems Authority to shape innovative solutions in regulatory and compliance. With precision as her hallmark, she embodies the role of Master of Document Precision and Document Control Expert, ensuring that every detail aligns with excellence.
Her work reflects a commitment to redefining QARA processes and empowering others to achieve extraordinary results.
“Excellence is not a destination, but a continuous journey of mastering the details that shape the bigger picture.”
AI Tools and Regulatory Thinking – Your Edge to Lead the Field
Our innovative AI solutions and proven Regulatory Thinking concept empower you to excel, simplify compliance, and dominate your industry.
With us, you don’t compete — you lead.