Empowering Medical Device Growth Across Europe
Based in Denmark, we combine Nordic precision with deep healthcare expertise to help medical device innovators navigate regulatory pathways, optimize usability and construct bulletproof market entry strategies.
End-to-End Market Acceleration
Usability & Safety: Human factors engineering for clinical efficacy and compliance.
Regulatory Excellence: Seamless navigation of EU-MDR and international pathways.
Commercial Strategy: Go-to-market business planning and distributor management.
Core Consultancy Services
Tailored expertise to take your medical technology from initial concept to commercial dominance.
Human Factors Engineering
Optimize device usability, reduce operational risk, and align with IEC 62366 standards for safer clinical outcomes.
• User Interface & Ergonomic Design
• Formative & Summative Usability Testing
• Use Error Analysis & Risk Mitigation
• Clinical Workflow Integration
Navigating Regulatory Pathways
Clear pathways through complex European and international regulatory environments to accelerate market access.
• EU-MDR & IVDR Strategy
• Technical Documentation & Dossier Prep
• CE Mark & FDA Submission Guidance
• Post-Market Surveillance (PMS) Setup
Strategic Business Planning
Data-driven commercial strategy and financial modeling designed for scalable medical device expansion across Europe.
• Go-To-Market (GTM) Strategy
• Distributor Selection & Contracting
• Reimbursement & Health Tech Assessment
• Financial Modeling & Valuation
Specialized Medical Categories
Join us in making a difference!
Contact us today
MedMarketExpand
4230- Denmark
Ninette Neel Chislett
CEO and Founder
Ninette boasts over two decades of documented experience in the international life sciences sector, complemented by a decade in business leadership. Her expertise covers the entire product lifecycle, with roles in prominent firms including Mediq (MedTech Distribution Services), AXON Communications (Health and Clinical Trial Communications), Novo Nordisk (Pharmaceuticals), Coloplast (Medical Devices), and Cook Biotech (Biotechnology). Furthermore, Ninette has adeptly overseen operations in Canada, focusing on Medical Device Import and Distribution in the Long-Term/Elder Care market, and in Denmark, providing consultancy services to the Life Sciences Industry.
Robert Chislett
Commercial Director, Strategic Sourcing and Partnerships
Robert brings 25 years of high-stakes experience in the medical device sector, specializing in the architecture and execution of commercial strategies that transform innovative technologies into market leaders. Robert's career is defined by a dual mastery of Direct and Indirect sales models, ensuring sustainable revenue growth across the diverse and complex landscape of the EMEA region and beyond.