To get proven medical devices and diagnostics into the hands of clinicians faster by giving manufacturers one experienced partner, from first concept to first revenue.
Managing Director
Commercial medtech executive with extensive experience in international market development, product launches and building high-performing multidisciplinary teams.
Commercial Director
Commercial diagnostics leader with three decades of experience in IVD, specializing in European market development, distributor networks and successful product launches.
Scientific Director
Life sciences executive with a master’s degree in molecular biology and extensive international experience in molecular diagnostics, global product strategy and clinical market development.
Communications Director
Communications strategist and creative director focused on brand positioning, integrated campaigns and translating complex ideas into clear, effective narratives.
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| Objective | Establish whether and how your product can succeed in specific countries. |
|---|---|
| What Emei does | IVDR/MDR classification and gap analysis of your technical documentation and performance evidence. Market sizing, competitor mapping and reimbursement review for target countries. |
| What you provide | Technical documentation, NMPA dossier, clinical and analytical data, quality system information. |
| Output | Written assessment report with a regulatory roadmap, evidence plan, target markets and budget. |
| Indicative timing | 6 to 10 weeks |
| Objective | Achieve compliant market access. First commercial and clinical adoption in a lead market. |
|---|---|
| What Emei does | Coordinate the conformity assessment route and notified body engagement. Set up EU regulatory roles, import and cold-chain logistics, post-market surveillance and vigilance. Establish key opinion leader engagement and first reference sites. |
| What you provide | Manufacturing, quality system (ISO 13485), document updates and product supply. |
| Output | Product legally on the EU market, lead-market launch and first reference sites. |
| Indicative timing | Typically 12 to 24 months, driven by device class and notified body capacity. |
| Objective | Build sustainable revenue across priority markets. |
|---|---|
| What Emei does | Distributor selection, contracting and training. Market-by-market registration where required. Evidence generation, publications and guideline engagement. |
| What you provide | Reliable supply, pricing framework, technical support and joint planning. |
| Output | Multi-country commercial network with agreed revenue targets. |
| Indicative timing | Ongoing, reviewed annually. |
