Let’s Discuss Your Compliance Needs

A short description of your device and its intended purpose, your target markets, and an idea of what documentation already exists. Nothing formal is required — the point of the call is to understand where you stand.

Typical durations: 2–4 months for Class I devices, 4–8 months for Class IIa, 6–12 months for Class IIb — depending on device complexity, existing documentation and Notified Body availability.

Yes. Collaboration is remote by default, and non-EU manufacturers targeting the EU market are a regular part of the work.

That is exactly what the free consultation is for. Describe the situation; identifying the right starting point is my job, not yours.

Yes — and portfolios bring efficiencies: shared documentation structures, one quality management system, coordinated registrations.

Projects are typically structured as deposit, milestone payments and balance. Terms are flexible and agreed before work starts.

Yes — as Person Responsible for Regulatory Compliance (PRRC) under Article 15 of MDR 2017/745, for manufacturers and authorised representatives, on monthly retainer models. See External PRRC Services.