Four EUDAMED modules have been mandatory since 28 May 2026. For certain existing devices, the transitional device-registration deadline is 28 November 2026.
Solution · RIM
Regulatory Information Management for ARAS PLM
Manage regulatory data, dossiers, UDI and EUDAMED centrally—natively integrated with ARAS Innovator.
Book an introductory call ↗CHALLENGE
Complexity needs structure.
Regulatory information is often scattered across spreadsheets, documents and email approvals, making reviews, submissions and audits unnecessarily difficult.
OUR APPROACH
From a data point to a reliable process.
RIM brings data models, roles, dossiers and approvals into one controlled platform and connects regulatory work directly to the Digital Thread.
REGULATORY NOW · 1 SEPTEMBER 2026
Current obligations. One shared data foundation.
EUDAMED and swissdamed already require dependable device data. The DPP rollout extends the same challenge to material, supplier and sustainability data.
Product registration in swissdamed has been mandatory since 1 July 2026; affected products already on the market have a transition period until 31 December 2026.
The EU DPP Registry and a testing environment have been available since 20 July 2026. The current testing phase precedes the first implementation deadline on 18 February 2027 for certain types of large batteries; other product groups will follow progressively.
PRODUCT IN ACTION
A look inside the product.
Selected demo views show how product data, validation and regulatory workflows come together in the application.
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What RIM delivers.
Modular, ready for integration into your system landscape and designed for long-term evolution.
UDI and EUDAMED management
Maintain Basic UDI-DI, UDI-DI and device master data centrally and prepare structured data for EUDAMED submissions.
Dossier and submission management
Manage dossiers, registration status and market deadlines with responsibilities, documents and a traceable history.
Regulatory roles and tasks
Guide reviews, tasks and approvals through defined roles and workflows and document each step transparently.
Controlled documentation
Link approved documents to products, dossiers and changes and use them under control throughout registration.
Regulatory change impact
Capture regulatory changes centrally, map affected product categories and derive traceable follow-up tasks.
Multilingual content
Together with PIM, maintain labelling and product content across languages and provide controlled content for dossiers and markets.
VALUE
A measurable difference in daily work.
✓Audit-ready traceability
✓Less manual dossier work
✓Consistent global submissions
DESIGNED FOR
Medical technologyPharmaDefenceManufacturingHigh-tech
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We demonstrate the solution using a concrete scenario and discuss the right implementation path.