Services

From business case to a QMS in production

We cover the full medical device life cycle with one head across all three stages: decide, comply and operate.

Stage 1 · Decide

Before you invest

Before you invest: is it worth launching? With which formulation? In which market order? Integrated financial, quality and market simulation.

Stage 2 · Comply

Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.

Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.

The risk management file your dossier requires in any jurisdiction.

Renewals, change management and post-market surveillance to keep your product current.

Stage 3 · Operate

The document QMS that sustains your operation once on the market: document control, e-signature, CAPA and a traceable audit trail.

Tell us where you are and we will give you a first read of the regulatory path, free of charge.