Core Services
Engineering-grounded regulatory and technical support for U.S. medical-device manufacturers, importers, and distributors — with particular depth in Brazil and LATAM market access, international supplier qualification, and device documentation.
1. Brazil & LATAM Market Access
Bring your device to Brazil without learning ANVISA the hard way.
ANVISA classification and registration strategy, technical dossiers, INMETRO/DIMEL conformity, ANATEL coordination, Portuguese labeling, Registration Holder guidance, and realistic timeline and cost mapping.
2. International Supplier Qualification & Factory Assessment
Find the quality problems before the container ships.
On-site and remote assessment, evidence reconciliation, IEC 60601 technical-file review, multilingual manufacturer negotiation, corrective-action follow-through, and regulatory-ready supplier packages.
3. Labeling & IFU Review
Documentation a clinician can actually follow.
Technical and regulatory review of IFUs, symbols, traceability, claims, intended use, Portuguese adaptation, service manuals, and real clinical workflow.
4. Technical Documentation & Risk File Review
Find the gaps before an auditor does.
Completeness, consistency, traceability, ISO 14971 risk files, IEC 60601 conformity evidence, and prioritized remediation for existing documentation.
5. QMSR Transition & 510(k) Readiness Assessment
Know where you stand before you commit budget.
A structured assessment of current evidence, documentation inventory, readiness gaps, comparative-documentation orientation, and a sequenced remediation roadmap.