Company · Partners

No platform without a network.

Certification institutes, integration partners, market access specialists – 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 – not because we could not do it ourselves, but because independence (for audits), specialization (for integrations), and local presence (for international markets) are structurally more important than vertical integration. 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 assessment institutes and Notified Bodies.

For formal certifications and evidence – ISO 13485 (QMS), BSI TR-03161 (per DiGA), BSI TR-03185 (process level), CE marking under MDR (for Class IIa with a Notified Body) – an independent assessment body is required in each case: TÜV Hessen for ISO 13485, BSI-recognized IT security assessment bodies like secuvera for the BSI TRs, Notified Bodies for CE in Class IIa. Our role: documentation and preparation. Their role: independent judgment.

Regulatory consulting

Clinical evaluation, MDR documentation, quality affairs.

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

Integrations & infrastructure

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

The mHealth Suite is integration-friendly – specialized endpoints are provided by domain vendors. For a BSI TR-03161-compliant identity provider we work with azuma. Integration with telemedicine platforms such as arztkonsultation is in preparation. Additional interfaces (pharmacy services, SHI billing, FHIR/ePA endpoints) are activated per project.

Market access

German market: regulatory bridge partners.

For the German market, the GKV-Spitzenverband and the BfArM are the relevant contacts, for whom we build the regulatory bridge. For emerging markets expansion (Go Beyond) we are currently in a scoping phase – 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 a growing portfolio of DTx customers, an established platform with documented interfaces, 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