Compliance & Regulatory Solutions for Industry

PLM · REGULATORY · DIGITAL THREAD

Connect product data.
Deliver regulatory & DPP.

We connect product, UDI, material, supplier and compliance data in ARAS PLM—for EUDAMED and swissdamed today and the phased Digital Product Passport rollout.

DPPARAS PLMDIGITAL THREADSERVICES

VERIFIED PARTNERSHIP

Aras Silver VAR, ISV

The official Aras partner profile lists mediatec.net with the certification “Silver VAR, ISV”.

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Aras 2026 Silver VAR PartnerAras 2026 ISV Partner
  • Since 2008
  • Markets: Germany · Switzerland · Poland
  • PLM · Regulatory · DPP

REGULATORY NOW · 7 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.

SWISSDAMED

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.

DIGITAL PRODUCT PASSPORT

The EU DPP Registry and a testing environment have been available since 20 July 2026. The Commission timeline names 18 February 2027 as the first implementation deadline for certain large-battery types; other product groups will follow progressively.

PRODUCT & SERVICES IN CONTEXT

Making product and services tangible.

A concrete DPP product view, supported by two transparent delivery paths for AI and Cloud Operations.

ANONYMISED PROJECT CONTEXTS

Experience without exposing customers.

The examples are based on documented scopes of work. Customer names, confidential metrics and contract details remain deliberately protected.

MEDMedical Device & Safety

Make system-test automation reproducible.

Manual system tests and an existing test environment needed to be transformed into a reusable automation foundation.

Scope

Technical analysis, automation of existing tests, reusable test steps, and verification of functionality and test coverage.

Test automationTraceabilitySafety-critical software
MBSEComplex product systems

Connect requirements, system models and evidence.

Requirements, system architecture, variants, tests and evidence needed to form a continuous Digital Thread.

Scope

MBSE in ARAS, SysML-oriented system model, verification and validation, change and configuration management, reporting.

ARAS PLMMBSEDigital Thread
B2BIndustry & distribution

Turn ERP data into a usable customer portal.

Orders, documents, product search, delivery addresses and open transactions needed to be accessible to business customers.

Scope

B2B portal, ERP interface, document delivery, order history, administration and hosting concept.

PortalERP integrationCustom software

COMPLIANCE & REGULATORY SUITE

End-to-end traceability from supplier to submission.

Four coordinated modules create a dependable Digital Thread—from central product information to the Digital Product Passport.

DIGITAL THREAD

One data model.
Many secure applications.

Product, marketing and regulatory data no longer lives in silos. It is reused under control, versioned and connected across system boundaries.

Explore the platform
  1. 01
    SourcesSuppliers & ERP

    Master data, BOMs and evidence

  2. 02
    Data coreARAS PLM

    Product structures, changes and relationships

  3. 03
    ApplicationsRIM · PIM · CEI

    Regulatory, marketing and integrations

  4. 04
    PublicationDPP

    Verify, approve and provide

  5. 05
    UseMarket & authorities

    Portal, QR, API and reporting

Governed end to end
VersionedTraceableReusable

SERVICES

Consulting, development and operations.

Specialists with deep technology and industry expertise—coordinated so solutions can scale seamlessly.

OUR APPROACH

Productive in four steps.

Structured enough for regulatory requirements and pragmatic enough for visible results.

01

Workshop

Clarify goals, processes and system landscape.

02

Solution Blueprint

Define target architecture, data model and roadmap.

03

Implementation

Build, integrate and validate iteratively.

04

Run & Evolve

Operate, measure and continuously improve.

INDUSTRY EXPERTISE

Focused on regulated industries.

Where product data, quality and compliance meet, we combine specialist knowledge with dependable technology.

View industries
2008founded

MEDIATEC.NET

Product expertise meets consulting depth.

Our multicultural team in Germany and Poland combines decades of IT experience with new ideas—from medical informatics and PLM to cloud and software development.

Meet the company

START A CONVERSATION

Ready to modernise your PLM landscape?

In 30 minutes, we clarify your target, current situation and the most useful next step.