Meet Our Team of Regulatory Affairs Professionals
Dedicated specialists ensuring medical device, in vitro diagnostics, and cosmetics compliance across Europe, UK, and Switzerland with over 30 years of combined regulatory expertise.
Our international team of regulatory affairs experts, quality assurance professionals, and compliance specialists ensure your medical devices is ready for the market. From initial market entry to ongoing post-market surveillance, we provide comprehensive support across all major markets.
Global Expertise, Local Knowledge
Our strategically located teams across Germany, the United Kingdom, Switzerland and China provide comprehensive regulatory support with deep understanding of local market requirements and cultural nuances. Each team member brings specialized expertise in medical device regulations, quality management systems, and post-market compliance.
Regulatory Excellence
Maintaining the highest standards in compliance and quality assurance
Client Partnership
Building long-term relationships based on trust and transparency
Continuous Learning
Staying ahead of evolving regulations and industry best practices
Global Perspective
Understanding international markets while respecting local requirements
Team Germany - European Regulatory Hub
Our German headquarter serves as the central hub for European regulatory affairs, housing our largest team of specialists with expertise spanning all aspects of medical device compliance, from MDR/ IVDR implementation to post-market surveillance.
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Franziska Constant
Regulatory Affairs Manager / PRRC
David Thaler
Business Advisor
Dr. Stephanie Vorwerk
Regulatory Affairs Expert
Annika Dreimann
Account & Regulatory Affairs Manager
Dr. Eva Steffens
Head of Regulatory Affairs
Dr. Juliana Del Sarto Jonitz
Sales & Regulatory Affairs Manager
Dr. Lisanne Korn
Account & Regulatory Affairs Manager
Danyel Elferink
Administration Manager
Raphael Berlth
Finance Manager
Sophia Rauch
Head of Human Resources
Raphael Gregarek
IT Manager
Julian Henke
IT Manager
Team United Kingdom - Post-Brexit Compliance Experts
Our UK team specializes in post-Brexit regulatory requirements, serving as your dedicated UK Responsible Person and ensuring seamless compliance with UK MDR 2002 (UKCA) and UK-specific requirements.
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Graham Oakey
UK Operations Manager
Tracey Oakey
UK Responsible Person
Team China - Asia-Pacific Regulatory Hub
Our China-based team provides essential support for local manufacturers looking to enter European markets, offering deep understanding of European regulations.
Amy Qian
Area Manager Asia
Grace Xue
Senior Regulatory Affairs Specialist
Violet Wei
Regulatory Affairs Specialist
Ready to Work with Our Expert Team?
Connect with our regulatory affairs specialists to discuss your medical device compliance needs. Our team is ready to provide personalized support for your market entry.
Phone
+49-251-32266-64Response Time
Within 24 hours (during business days)