Trusted by manufacturers and importers
Selling into Europe from outside the EU? We become your regulatory arm in Italy: CE marking, technical documentation, UDI/EUDAMED, packaging (PPWR), and the importer & authorised-representative roles — coordinated directly with your team, in English, in your timezone.
Manufacturer outside the EU, EU importer, or an early-stage MedTech — the starting point differs, and so does the plan.
We handle classification, CE marking, UDI/EUDAMED and the importer / authorised-representative roles, working directly with your team in English.
EU Market Access →Under MDR Art. 13 and PPWR Art. 17 you are legally the "producer" of what you place on the market. We keep your technical file current and audit-ready, with ongoing coverage.
Compliance Desk →Device classification, MDR/ISO 13485 gap analysis, technical file and go-to-market strategy — the foundations that save you from redoing everything later.
Readiness Check →Modular services: take only what you need, when you need it.
Risk class and compliance route defined per Annex VIII, with a traceable rationale.
We review your existing documentation, find the gaps against MDR and ISO 13485, and close them.
The Person Responsible for Regulatory Compliance as a service — compliant without a full-time hire.
UDI-DI coding, actor and device registration, traceability ready for EUDAMED.
Packaging obligations (Reg. EU 2025/40), producer register, declarations and CONAI contributions — deadlines managed for you.
We run a mock audit, train your team and stand beside you during the notified body inspection.
Not generalists touching a bit of everything: medical-device specialists, with a direct bridge to non-EU manufacturers.
PRRC (Art. 15 MDR), ISO 13485 and 9001 quality systems, AIFOD (UN) members. Specialists, not generic consultants.
Technical files and QMS built to pass the notified body inspection, with a real track record on devices up to Class IIa.
We coordinate non-EU manufacturers directly, in English, handling importer and authorised-representative roles. The expertise generalists don't have.
In 10 days we know where you're exposed, and with what priority.
What to do, in what order, with clear timing and ownership.
We build the technical file, QMS and registrations. PRRC sign-off included.
Compliance Desk: regulatory updates and obligations managed over time.
"RIH didn't stop at certification. Their strategic support was the real added value, letting us pass the Ministry of Health audit successfully."
"With RIH we expanded our offering with a PRRC service. Not just consulting, but a partner that strengthened our market position."
"RIH accelerated our innovation process and let us navigate regulatory complexity smoothly, with a clear strategic vision for the future."
"They structured the company to take part in public tenders. Their end-to-end vision was crucial to our growth."
€2,900
In 10 working days you know exactly where you're exposed and what to do, with a prioritised plan. It's also the easiest way to start working together without committing to a long project up front.
Book a callYes. We act as your regulatory arm in Italy: CE marking, MDR/IVDR technical documentation, UDI/EUDAMED registration, and the importer and authorised-representative roles — coordinating directly with your team, in English, in your timezone.
With a Regulatory Exposure Scan (€2,900). In 10 working days you get a clear map of your regulatory exposure and a prioritised action plan, with no commitment to a long project.
The Person Responsible for Regulatory Compliance (Art. 15 MDR) is mandatory for medical device manufacturers. We provide it as a service — compliant without a full-time hire.
We use AI to speed up analysis and first drafts, but every file is validated by a PRRC certified under Art. 15 MDR. AI for speed, human expertise for validity — documents built to withstand an audit.