What we can do for you
Our Services
As a CRO and consultancy Qmed supports MedTech innovators across the full path from planning and evidence strategy to clinical execution, market access, and post-market work. Some clients need a single partner to carry the project end to end – often referred to as ‘full-service’ – Others need experienced specialists to step into one part of the journey – some call it a ‘fractional-model’ – We do both.
From the start, we put the right team around the project. That means clinical and regulatory specialists are aligned early, even when different specialists become active at different stages. The result is a clear path from day one, fewer disconnects between workstreams, and less expensive rework later.
Plan
The most critical decisions in MedTech are often made early — and often under uncertainty.
Classification, regulatory strategy, clinical evidence, and quality foundations define what’s possible later. Delaying these decisions typically leads to complexity, delays, and increased cost.
We help you define the right path early — not react to problems later.
Our approach combines:
- Understanding your product, ambition, and constraints
- Defining a clear regulatory and clinical strategy
- Aligning evidence, studies, and quality systems from the start
Key areas of support:
- Clinical development strategy and study design
- Clinical evidence strategy aligned with regulatory and market objectives
- Regulatory pathway definition and classification (MDR / IVDR)
- Alignment of clinical, regulatory, and product strategy from early stage
- Scalable quality system foundations (ISO 13485)
Execute
Once the path is clear, execution becomes the differentiator.
This is where many projects succeed or fail — not because of strategy, but because of weak structure, coordination, or control.
We can take full responsibility for study execution or support specific parts of your organisation with targeted clinical trial services.
Our capabilities include:
- Integrated clinical trial management — end-to-end or modular
- Data management, analytics, and clinical evidence generation
- Site management, monitoring, and operational oversight
- Project leadership across clinical, regulatory, and quality activities
- Alignment of execution with regulatory strategy and clinical objectives
- Quality and compliance support across all workstreams
Market Access
As products move towards market access, the challenge shifts.
It’s no longer about defining the path — it’s about proving that everything aligns.
Many organisations focus on individual documents. The real challenge is ensuring the full regulatory story is consistent, complete, and defensible.
We help bring together clinical evidence, regulatory documentation, and system-level consistency.
Key areas:
- Clinical evidence strategy and Clinical Evaluation Reports (CER)
- Technical documentation and MDR submission readiness
- Alignment of clinical, regulatory, and product claims
- UDI & EUDAMED and regulatory system requirements
- Reimbursement and market access strategy
Post-Market
Post-market isn’t the end of the journey — it’s where regulatory expectations intensify.
Surveillance, evidence updates, reporting, and clinical follow-up become critical to maintaining compliance and market position.
We help you build structured, sustainable post-market systems that connect to the rest of your product lifecycle.
Our support includes:
- Post-market surveillance (PMS) systems and structured processes
- PMCF strategy, study design, and execution
- PSUR and ongoing regulatory reporting
- Alignment of post-market activities with clinical evidence and regulatory strategy
- Continuous regulatory and quality support across the product lifecycle
How we Work
Our way of working is simple: listen first, lead with clarity, and deliver with experienced specialists close to the work. We don’t believe complex projects need complex language. They need clear thinking, strong ownership, and people who know what is coming before it becomes a problem.