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Consulting

Competence for regulated development
HomeConsulting

Consulting for cyber security, process management, project management, regulatory affairs, technology & validation.

Innovative software solutions and medical products are not created by chance - they are the result of clear structures, well thought-out processes and well-founded decisions. This is precisely where sepp.med 's consulting expertise comes in: We support companies from regulated and technology-driven industries with practical, standard-compliant and goal-oriented advice - from the initial requirement to the successful market launch.

Do you have any questions about our consulting services?

Our focal points at a glance

Our focal points at a glance

Ein dunkelblauer Schildumriss mit einem Vorhängeschloss-Symbol in der Mitte, das für Sicherheit oder Schutz steht. Ein weißes Vorhängeschloss-Symbol befindet sich in der Mitte eines Schildes vor einem hellgrauen Hintergrund, der Sicherheit und Schutz symbolisiert.
Cybersecurity
Identification, assessment and protection of vulnerabilities - including threat modeling, secure-by-design, NIS-2, ISO 81001-5-1 and industry-specific security standards.
Ein dunkelblaues Symbol für ein leeres Blatt Papier mit einer gefalteten Ecke, begleitet von einem Bleistift unten rechts, der das Schreiben oder Bearbeiten eines Dokuments symbolisiert. Ein einfaches Symbol, das ein Dokument mit einem darüber positionierten Bleistift zeigt, was auf die Bearbeitung oder das Schreiben auf dem Dokument hindeutet.
Project management
Supporting your projects with modern methods, clear role models (e.g. SCRUM, V-model) and practical risk management - for more planning security and reliability.
Zwei gekrümmte Pfeile, die einen Kreis bilden, von denen einer nach oben und der andere nach unten zeigt, stellen ein Aktualisierungs- oder Neuladesymbol dar. Zwei hellgraue Pfeile bilden einen Kreis, wobei jeder Pfeil auf das Ende des anderen Pfeils zeigt, was eine Endlosschleife oder ein Aktualisierungssymbol auf weißem Hintergrund darstellt.
Process consulting
Optimization and harmonization of your development and quality processes. We analyze, model and improve - e.g. according to ISO 13485, ISO 62304 or Automotive SPICE.
Ein einfaches, dunkelblaues Häkchensymbol auf hellgrauem Hintergrund. Ein einfaches weißes Häkchensymbol auf hellgrauem Hintergrund.
Validation / Regulatory Affairs
Advice on regulatory frameworks for medical devices and health software - MDR, FDA, ISO standards and much more.

Consulting on the sepp.med blog

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CRA Reporting Obligation: What Really Has to Happen in the First 24 Hours
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AI Act meets MDR: Why a second QMS is the wrong path
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5 warning signs that your MedTech QMS isn’t ready for the AI Act
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When FMEA meets AI: Why isolated silos create audit risks
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As the Operational Design Domain expands, traditional tests fail: SOTIF in automotive practice
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Validation at its limits? Why document-heavy CSV is reaching its limits in medical technology
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Hybrid Diagnosis-Related Groups (Hybrid DRG): Hospital IT faces the test of cross-sectoral integration
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The “Deutschland-Stack”: What “DevSecOps only” actually means
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Reasoning AI under scrutiny: How to make explainability verifiable
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NIS-2: More than 18,000 companies are missing from the BSI portal. What’s behind this?
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The EU AI Act by industry: What distinguishes the medtech, automotive, finance, and administrative sectors?
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The EU AI Act in 2026: What every company using AI software needs to know now
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How to secure AI systems: Why traditional testing is not enough
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Securing automotive software: Automation, safety and security
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SAP IS-H will be discontinued in 2030: How to future-proof your hospital IT now
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Quality assurance for automotive software: From testing to ASPICE 4.0
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Homologation: Why certification determines market success or failure
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Cyber Resilience Act and AI in medical technology
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Quishing, smishing, and more
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Agile testing with a plan: Why MBTsuite Next makes the difference
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Cybersecurity meets ASPICE: How secure processes are shaping the future of automotive
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Safety and testing concepts for safe autonomous driving
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Threat-modeling
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Automotive SPICE 3.1 vs 4.0
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Creative retrospectives: playful team improvement
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Our understanding of testing in the automotive industry: quality and safety for the mobility of tomorrow
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IT due diligence: the key to successful practice integration
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Agile methods in software development: flexibility and efficiency in a dynamic market environment
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S3HIFT – “Cyber security measures for automotive and medtech products”
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NIS2 Directive – Increased cyber security requirements and their impact in the EU
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Automotive SPICE vs. Agility in modern software development – a contradiction
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Agile and efficient through outsourcing of software tests
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Ransomware – An exciting insight and helpful tips
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On the digital security path: A comprehensive approach to strengthening security resilience
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Creating value from data – using the example of a radiation clinic
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Future Healthcare: AI in medicine and medical technology
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Preparing for the EU Cyber Resilience Act – what your company needs to consider now
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    phone: +49 9195 931-0
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