Product development stages

We structure product development into five main stages. Choose the pathway that matches your stage and take a look what the Nordic Proof network has to offer.

Shortcuts

Early concept
Prototype & development
Clinical validation
Pre-market & regulatory approval
On the market

Phase 1

Early concept

Validate user needs and define product requirements early, through structured dialogue with clinical stakeholders.

Typical duration: 4-12 weeks

Details

What you should have ready

Early concept or hypothesis
Willingness to iterate based on feedback
Basic product documentation and pitch

What we deliver

Expert panel
Insight and mapping of clinical workflow
Stakeholder interview summaries
Regulatory roadmap

Phase 2

Prototype & development

Turn validated concepts into working prototypes, with technical testing and iterative refinement grounded in real clinical conditions.

Typical duration: 3–9 months

Details

What you should have ready

Defined product requirements and intended use
Early concept validated with clinical stakeholders
Initial technical specifications

What we deliver

Prototype testing in relevant clinical environments
Usability testing
Technical feedback from clinical users
Risk management support

Phase 3

Clinical validation

Test performance, safety, and clinical value in structured settings, generating the evidence needed to support your product's claims.

Typical duration: 6–24 months

Details

What you should have ready

Near-final or final product
Defined test protocol and endpoints
Regulatory strategy in place (MDR classification, where relevant)
Necessary ethical and data approvals (GDPR, ethics committee)

What we deliver

Clinical trial or structured validation in partner environments
Access to clinical data, registry data and patient populations
Documentation of clinical performance and safety
Evidence to support regulatory submission
Research services

Phase 4

Pre-market & regulatory approval

Typical duration: 6-24 months

Details

What you should have ready

Clinical evidence and validation results
Technical documentation and risk file

What we deliver

Market knowledge and demonstration environments
Feedback from end users ahead of launch

Phase 5

On the market

Support post-market follow-up and continuous improvement, with structured studies and real-world insight from clinical use.

Typical duration: Ongoing

Details

What you should have ready

Approved product in clinical or real-world use (CE marked, where relevant)
Post-market surveillance plan (PMS/PMCF, where relevant)
Framework for collecting user and performance data

What we deliver

Post-market clinical follow-up studies in partner environments
Structured user feedback from clinical settings
Cost-benefit analysis

Meny

Product development stages

Shortcuts

Early concept

What you should have ready

What we deliver

Prototype & development

What you should have ready

What we deliver

Clinical validation

What you should have ready

What we deliver

Pre-market & regulatory approval

What you should have ready

What we deliver

On the market

What you should have ready

What we deliver

Ready to take the next step?