International MedTech companies face complex challenges when entering the German healthcare market. At sepp.med, we support you from the initial idea through to the successful integration of your medical device - including technical integration, MDR-compliant approval and market launch in clinics and surgeries.
International MedTech companies often encounter regulatory, technical and cultural barriers when entering the German healthcare market. sepp.med offers you practical solutions to overcome these challenges efficiently:
Knowing which hurdles to expect is one thing. Knowing exactly how to clear them is another.
Our whitepaper gives you a structured overview of the regulatory, technical, and operational requirements for entering the German healthcare market, including practical guidance on where to start and how to reduce your time-to-market.
As an experienced partner, we provide international MedTech manufacturers with comprehensive support - from technical integration to regulatory approval and market development.
Development of customized interfaces (e.g. HL7, FHIR, DICOM)
Middleware development and adaptation to hospital processes
Smooth integration into existing hospital IT systems (HIS, RIS, PACS)
Preparation and revision of technical documentation according to MDR
Support with CE certification and clinical evaluation
Ensuring compliance with all relevant EU and national regulations
Linguistic and cultural adaptation of UI, user guidance and documentation
GDPR-compliant processing and storage of patient data
UX optimization for clinical applicability and acceptance in everyday life
Initiation and support of pilot projects with German clinics
Access to relevant reference customers and opinion leaders in the healthcare sector
Development and expansion of sales, service and partner networks
An increasing number of medtech products use AI components for image analysis, diagnostic support, and clinical decision support, among other applications. Those who wish to sell these products in the EU must comply with two sets of regulations: the Medical Device Regulation (MDR) and the EU AI Act. The latter generally classifies AI-based medical devices as high-risk AI systems.
We support you in considering both sets of regulations from the outset and implementing them efficiently.
Our services include:
This allows you to avoid duplication of effort and create consistent evidence for market access in Germany and Europe.
Learn more: Quality assurance for AI systems | AI consulting
CE marking according to MDR, complete technical documentation, clinical evaluation if applicable.
We develop individual interfaces and ensure the connection to systems such as HIS, RIS or PACS.
Depending on the degree of maturity and product complexity: typically 6-18 months - we help to shorten this period.
Yes, we arrange targeted pilot projects with selected clinics.
Yes, we localize UI, training materials and product documentation for the German-speaking market.
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