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Sarah Panten
Co-founder Speaker of the Board @Medical Device Knowledge Units Mdku E.V
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WORK HISTORY
Co-founder Speaker of the Board @Medical Device Knowledge Units Mdku E.V
Impact & Results- Co-founded a non-profit industry initiative to standardise data for medical device technical documentation- Driving the development of a unified data model, published as DIN SPEC 91509- Contributing to clearer regulatory language and accelerated digitalisation across the industryKey Skills:Data Models · Regulatory Standardisation · Stakeholder Management · Thought Leadership
EDUCATION
University of Applied Sciences Hamburg
Dipl.-Ing.
TÜV SÜD Akademie
Training for trainers
International Requirements Engineering Board (IREB)
Certified Professional for Requirements Engineering - Foundation Level
TÜV SÜD Akademie
Update ISO 13485:2016
TÜV SÜD Akademie
Auditor for internal/supplier audits
Koordinierungszentrum für klinische Studien Heidelberg
Project manager clinical trials
TÜV SÜD Akademie
Risk Management according to ISO 14971
TÜV SÜD Akademie
Medical Device Regulation (MDR) in Detail
SKILLS
ABOUT SARAH PANTEN
My focus: How can MedTech finally move from documents to data?I help organisations digitalise their MDR/IVDR lifecycle processes in a way that is compliant, scalable and actually usable in daily work. The goal: reducing regulatory effort while enabling faster innovation across the medical device lifecycle.With > 20 years of experience in medical technology, I work at the intersection of regulatory, quality, IT and business. My focus is on turning complex regulatory requirements into practical digital solutions that teams actually use-My turning point came in 2014, when I introduced Siemens Polarion into medical device product development and experienced firsthand how much efficiency is lost with Word, Excel and PDF-based documentation. Since then, I’ve been driving data-driven digitalisation: from strategy to hands-on implementation.Today, I’m co-founder and Managing Director of avasis solutions GmbH (part of the avasis group), developing medical device-specific digital solutions based on the Siemens Polarion technology. I\'m also co-founder and board member of the nonprofit Medical Device Knowledge Units (MDKU) e.V, driving the development of a unified data model for medtech technical documentation (DIN SPEC 91509) to create clearer regulatory language and accelerate digitalisation across the industry. Since 2012, I have shared my experience as a trainer, workshop moderator and conference speaker. I love using innovative, interactive methods to make complex regulatory topics tangible, visual and practical - because sustainable transformation happens when people truly understand and engage-On LinkedIn, I share insights on- MedTech digitalisation & document-to-data transformation- Experiences from co-creation, standardisation work and ecosystem collaboration- Reflections on leadership, personal growth and leading change in regulated environments-If you’re working on digital transformation in MedTech, or leading people through regulatory complexity, follow along. I share what works, what doesn’t, and what we’re learning on the way.Digital transformation only succeeds when people grow with it - so let\'s grow together!
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