Take only what you need, when you need it. The prices below are indicative and confirmed after the Regulatory Exposure Scan, based on device class and the state of your documentation.
In 10 working days: a map of your regulatory exposure and a prioritised action plan. The easiest way to start, with no commitment to a long project.
Risk class and compliance route per Annex VIII, with a traceable rationale ready for the notified body.
Gap analysis against MDR and ISO 13485 and an operational plan to close them; building or remediating the technical file.
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 of conformity and CONAI contributions — deadlines managed for you.
Verify the compliance of what you import or distribute before placing it on the market, so you don't inherit someone else's risk.
Fast recovery of non-conforming files and QMS, across three severity levels, to arrive audit-ready.
Continuous coverage: regulatory updates, obligations and a technical file kept current over time.
Full EU market-access package for non-EU manufacturers: classification, CE marking, UDI/EUDAMED and importer/representative roles.
Begin with the Regulatory Exposure Scan: in 10 days you know exactly where you're exposed and which services you actually need.
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