Company · Partners

No platform without a network.

Test labs, certification bodies, regulatory consulting, integration partners – who works in the orbit of DUX and why this division of labor is relevant to your project.

Book a call with Christoph Partner types

Why partners

The platform handles a lot – but not everything. The partners handle the rest.

The mHealth Suite covers product development, regulatory documentation, cybersecurity evidence, and ongoing operations. It does not cover: certification audits by independent bodies, specific integrations into medical infrastructure, national market entry outside Germany, consulting-heavy regulatory support on the customer side.

That is where we work with partners: certification audits require an independent body, integrations require specialization, international markets require local presence. This page shows which partner types come in at which project phase.

The partner types

Four categories of partners – depending on project phase.

Audit & certification

Independent test labs and certification bodies.

Formal evidence requires an independent body. Our ISO 13485-certified quality management system (TÜV Hessen) is audited externally. For BSI TR-03161 (per DiGA) we work with secuvera GmbH, BSI-recognised test lab for BSI TR-03161; secuvera is also the test lab for our TR-03185 process certificate. Our role: documentation and preparation. Their role: independent judgment.

CE marking under the MDR requires a Notified Body from Class IIa upwards (Article 52 MDR); DiGA can be Class I, IIa or IIb.

Regulatory consulting

Clinical evaluation, MDR documentation, quality affairs.

For customers who do not want to carry their regulatory work in-house, we work with CONSULTYS Medical GmbH, our regulatory and QM consulting partner (intended purpose, risk management, clinical evaluation). The same service is also available as a “Regulatory Concierge” add-on in our engagement model. For the manufacturer role: be-on-market GmbH, our partner for placing medical devices on the market (legal manufacturer under the MDR).

Integrations & infrastructure

Identity, ePA, FHIR, pharmacies, telemedicine, billing.

The mHealth Suite is integration-friendly – specialized endpoints are provided by domain vendors. We work with azuma. A telemedicine integration module is available; the connection to a specific provider is set up per project. Further modules – such as pharmacy integration, electronic patient record and activation-code redemption – are activated per project.

Market access

German market: BfArM and GKV-Spitzenverband.

In the German market, the BfArM decides on the manufacturer’s application for listing in the DiGA directory (Section 139e SGB V); the manufacturer agrees the reimbursement amount with the GKV-Spitzenverband (Section 134 SGB V). Both are counterparts of the manufacturer, not DUX partners. We prepare the evidence on the platform. For emerging markets expansion (Go Beyond): internationally, DUX is in market entry. We are building targeted partnerships, but are not yet operational in individual target markets. If you are interested in a pilot market, let us talk.

Interested in partnership

What we need from partners and what we bring.

We are continuously looking for partners in three profiles: national distribution partners in emerging markets, specialized integration providers in the German health infrastructure, and regulatory consulting with industry depth.

What we bring: access to our customer portfolio (five DiGAs under contract on the mHealth Suite), the mHealth Suite with 90+ pre-validated modules, a co-marketing framework with joint customers, and a clear division of labor (we do not fight over your margins as long as we run our platform).

If your company fits one of these profiles, let us talk.

… and you?

Partnership, integration, or customer project – thirty minutes on the phone.

Tell us where you want to plug in: as a partner, as an integrator, as a customer with a clinical concept. We will show what fits the platform – and whom else we need at the table.
Book a call with Christoph