Certified Regulatory Experience
We’ve taken hundreds of products through development & clearance, working with global regulatory bodies including the FDA, MHRA, and EMA – guided by our ISO 13485 certification standards.
Pre & Post Clearance Guidance
Our regulatory & quality specialties, include:
• Regulatory Planning
• International Registrations
• Adverse Event Handling
• Rapid Response to Non-Conformities
• Quality Management System Guidance & Buildout
• Cybersecurity
• SaaMD & Ai
• Supplier Management
No delays. Just experts.
We’ve cleared hundreds of products and know the fastest, safest path from early-stage development to market. Our regulatory team works shoulder-to-shoulder with design and engineering—no silos, no handoffs—so we spot risks early and keep your project moving. Whether you’re navigating initial clearance or facing post clearance challenges, our seasoned experts and are here to answer your questions.
We’ve been there, and we’ll get you through it.
• Risks assessments on cleared devices
• Design to approval, end-to-end expertise
• Subject matter experts (SMEs) at design & regulatory stages
• EUMDD to EUMDR transitions
• Labeling & UDI Design
• Building complex design history files
• Re-baselining 510Ks
• Gap assessment
• Pre-submissions
• CER generations
• Preparation of technical files
• Build-out of suppliers & qualifications
• Deviation, corrective action, preventative action (CAPAs)
• Good manufacturing practice (GMP) compliance services
Questions?
We’ve got answers.
Stefanie brings over 10 years of experience in regulatory affairs and quality assurance, guiding a wide range of medical devices and pharmaceutical products through complex global requirements.
She has successfully managed FDA 483 responses, 510(k) submissions, and audits across U.S., EU, APAC, and LATAM markets.
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Known for her collaborative and solutions-driven approach, Stefanie helps both startups and established companies navigate evolving regulatory landscapes with creative, compliant strategies.