Zum Inhalt springen
  • Industries
    Industries
    • Future Mobility
    • Future Healthcare
    • Future Industries
    • Future Fintech
    • Future eGovernment
  • Consulting
    Consulting
    • Artificial Intelligence
      Artificial Intelligence
      • AI-Assisted Software Testing
      • Quality Assurance for AI Systems
      • AI Integration for Your Business
    • Cybersecurity
      Cybersecurity
      • Threat Modeling
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
    • Process Consulting
      Process Consulting
      • Application Lifecycle Management (ALM)
      • Requirements Engineering
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • MedTech Software Development According to ISO 62304
    • Project Management
      Project Management
      • Interim Project Management
      • Introduction of Agile Methods
    • Validation / Regulatory Affairs
      Validation / Regulatory Affairs
      • Automotive Software
      • Medical Software
      • Medical Software Validation Following ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
    • Automotive Consulting
      Automotive Consulting
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • Automotive Software Validation
    • Healthcare and MedTech Consulting
      Healthcare and MedTech Consulting
      • Our Consulting Services
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
      • MedTech Software Development
      • MedTech Software Validation
      • Validation: ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
  • Engineering
    Engineering
    • Software Development
      Software Development
      • Agile Systems Engineering
      • Agile Software Engineering
      • DevOps
    • Software Test
      Software Test
      • AI-Assisted Software Testing
      • Agile Software Testing
      • Test Management
      • Acceptance Tests
      • HiL-Testing / Embedded Testing
      • Load and Performance Tests
      • Pentesting & Fuzzing
      • Robustness Tests
      • Accessibility Testing
  • AI Solutions
    AI Solutions
    • AI-Assisted Software Testing
    • Quality Assurance for AI Systems
    • AI Integration for Your Business
  • Academy
    Academy
    • Training Overview
    • Your Advantages
    • Webinars
  • Company
    Company
    • Success Stories
    • Events
    • Press
    • Social Commitment
    • Partner
    • Awards
    • Certifications
  • Career
    Career
    • Open Positions
    • Your Job at sepp.med
    • Inside sepp.med
    • Application & Entry
    • Speculative Application
  • Webinars
  • Blog
  • Events
  • Contact
  • MBTsuite Next
EN | DE
  • Industries
    Industries
    Industry solutions for regulated markets - secure, efficient and future-oriented.
    Read more
    • Future Mobility
    • Future Healthcare
    • Future Industries
    • Future Fintech
    • Future eGovernment
    • Future Mobility
    • Future Healthcare
    • Future Industries
    • Future Fintech
    • Future eGovernment
  • Consulting
    Consulting
    We provide you with comprehensive advice on all aspects of software and product development - from cyber security and process consulting to regulatory affairs. Efficient, secure and compliant.
    Read more
    • Artificial Intelligence
      • AI-Assisted Software Testing
      • Quality Assurance for AI Systems
      • AI Integration for Your Business
    • Cybersecurity
      • Threat Modeling
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
    • Process Consulting
      • Application Lifecycle Management (ALM)
      • Requirements Engineering
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • MedTech Software Development According to ISO 62304
    • Project Management
      • Interim Project Management
      • Introduction of Agile Methods
    • Validation / Regulatory Affairs
      • Automotive Software
      • Medical Software
      • Medical Software Validation Following ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
    • Automotive Consulting
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • Automotive Software Validation
    • Healthcare and MedTech Consulting
      • Our Consulting Services
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
      • MedTech Software Development
      • MedTech Software Validation
      • Validation: ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
    • Artificial Intelligence
      • AI-Assisted Software Testing
      • Quality Assurance for AI Systems
      • AI Integration for Your Business
    • Cybersecurity
      • Threat Modeling
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
    • Process Consulting
      • Application Lifecycle Management (ALM)
      • Requirements Engineering
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • MedTech Software Development According to ISO 62304
    • Project Management
      • Interim Project Management
      • Introduction of Agile Methods
    • Validation / Regulatory Affairs
      • Automotive Software
      • Medical Software
      • Medical Software Validation Following ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
    • Automotive Consulting
      • Automotive SPICE®
      • Automotive SPICE® Assessment
      • Automotive Software Validation
    • Healthcare and MedTech Consulting
      • Our Consulting Services
      • Cybersecurity Consulting for Healthcare Facilities (NIS2)
      • MedTech Software Development
      • MedTech Software Validation
      • Validation: ISO 13485 and ISO 62304
      • MedTech Market Entry in Germany
  • Engineering
    Engineering
    Structured engineering for complex systems and regulated markets.
    Read more
    • Software Development
      • Agile Systems Engineering
      • Agile Software Engineering
      • DevOps
    • Software Test
      • AI-Assisted Software Testing
      • Agile Software Testing
      • Test Management
      • Acceptance Tests
      • HiL-Testing / Embedded Testing
      • Load and Performance Tests
      • Pentesting & Fuzzing
      • Robustness Tests
      • Accessibility Testing
    • Software Development
      • Agile Systems Engineering
      • Agile Software Engineering
      • DevOps
    • Software Test
      • AI-Assisted Software Testing
      • Agile Software Testing
      • Test Management
      • Acceptance Tests
      • HiL-Testing / Embedded Testing
      • Load and Performance Tests
      • Pentesting & Fuzzing
      • Robustness Tests
      • Accessibility Testing
  • AI Solutions
    AI Solutions
    Artificial intelligence that works: in software testing, in your products, and in your business processes. Secure and compliant.
    Read more
    • AI-Assisted Software Testing
    • Quality Assurance for AI Systems
    • AI Integration for Your Business
    • AI-Assisted Software Testing
    • Quality Assurance for AI Systems
    • AI Integration for Your Business
  • Academy
    Academy
    Training courses, workshops and webinars on software quality, safety & security - well-founded, practical and state-of-the-art.
    Read more
    • Training Overview
    • Your Advantages
    • Webinars
    • Training Overview
    • Your Advantages
    • Webinars
  • Company
    Company
    sepp.med - a partner for secure software solutions in regulated markets for over 40 years.
    Read more
    • Success Stories
    • Events
    • Press
    • Social Commitment
    • Partner
    • Awards
    • Certifications
    • Success Stories
    • Events
    • Press
    • Social Commitment
    • Partner
    • Awards
    • Certifications
  • Career
    Career
    BE YOU - WITH US
    Do you share our enthusiasm for software? Then become part of sepp.med.
    Read more
    • Open Positions
    • Your Job at sepp.med
    • Inside sepp.med
    • Application & Entry
    • Speculative Application
    • Open Positions
    • Your Job at sepp.med
    • Inside sepp.med
    • Application & Entry
    • Speculative Application
  • Webinars
  • Blog
  • Events
  • Contact
  • MBTsuite Next
EN | DE

Validation & Regulatory Affairs

for automotive software and medical products
HomeConsultingValidation & Regulatory Affairs

In regulated markets such as medical technology or the automotive industry, the compliant validation of your software solutions determines quality, safety - and market access. International standards such as ISO 13485, ISO 62304 or ASPICE place high demands on your development processes, documentation and quality assurance.

With sepp.med, you receive practical support for all regulatory requirements - from the validation strategy to implementation and audit preparation. We combine technical expertise with a deep understanding of standards and help you to make your software secure, traceable and certifiable.

Do you have any questions about our offer?

Our focal points at a glance

Our focal points at a glance

Ein einfaches, minimalistisches Symbol eines Autos von vorne gesehen, mit sichtbaren Scheinwerfern und einem Kühlergrill, vor einem hellgrauen Hintergrund. Ein einfaches, minimalistisches Symbol eines Autos von vorne gesehen, mit sichtbaren Scheinwerfern und einem Kühlergrill, vor einem hellgrauen Hintergrund.
Automotive software
Validation of safety-critical software for OEMs and Tier 1 suppliers in accordance with Automotive SPICE® and SQIL specifications.
Ein schwacher, grauer Umriss eines Stethoskops mit einem Häkchen daneben, das die medizinische Zulassung oder Gesundheitsprüfung symbolisiert, auf hellem Hintergrund. Ein schwacher, grauer Umriss eines Stethoskops mit einem Häkchen daneben, das die medizinische Zulassung oder Gesundheitsprüfung symbolisiert, auf hellem Hintergrund.
Medical software
Validation of medical software in accordance with EU MDR, FDA, and ISO/IEC standards – for secure approval and auditable processes.
Ein einfaches weißes Schildsymbol mit einem Kreuz in der Mitte, das Schutz oder Gesundheit symbolisiert, auf einem hellgrauen Hintergrund. Ein einfaches weißes Schildsymbol mit einem Kreuz in der Mitte, das Schutz oder Gesundheit symbolisiert, auf einem hellgrauen Hintergrund.
Medical software validation following ISO 13485 and ISO 62304
Secure implementation of regulatory requirements for the software lifecycle – including risk management, traceability, verification, and validation.
A simple, gray icon of a storefront with a striped awning and a large plus sign in the lower right corner, suggesting the option to add a new store or location. A simple, gray icon of a storefront with a striped awning and a large plus sign in the lower right corner, suggesting the option to add a new store or location.
Market entry for international medtech companies
We support companies entering the German market by providing expertise in MDR compliance, CE certification, and local market development.

Validation and regulatory affairs on the sepp.med blog

Article
AI Act meets MDR: Why a second QMS is the wrong path
Read more
Article
5 warning signs that your MedTech QMS isn’t ready for the AI Act
Read more
Article
As the Operational Design Domain expands, traditional tests fail: SOTIF in automotive practice
Read more
Article
Validation at its limits? Why document-heavy CSV is reaching its limits in medical technology
Read more
Article
Reasoning AI under scrutiny: How to make explainability verifiable
Read more
Article
The EU AI Act by industry: What distinguishes the medtech, automotive, finance, and administrative sectors?
Read more
Article
The EU AI Act in 2026: What every company using AI software needs to know now
Read more
Article
How to secure AI systems: Why traditional testing is not enough
Read more
Article
Securing automotive software: Automation, safety and security
Read more
Article
Quality assurance for automotive software: From testing to ASPICE 4.0
Read more
Article
Homologation: Why certification determines market success or failure
Read more
Article
Cyber Resilience Act and AI in medical technology
Read more
Article
Preparing for the EU Cyber Resilience Act – what your company needs to consider now
Read more

Get in touch with us!

    * Pflichtfeld

    Foto von Matthias Lutz
    Your contact
    Matthias Lutz
    Business Development Consultant
    Telefon Telefon Telefon Telefon +49 (0) 9195 - 931 - 239
    Validation & Regulatory Affairs Our focal points Blog articles Contact
    Your project deserves the best!
    sepp.med gmbh
    Gewerbering 9
    91341 Röttenbach
    Germany
    phone: +49 9195 931-0
    mail: info@seppmed.de
    • Services 
      • Consulting 
      • Engineering 
    • Company 
      • Success-stories 
      • Events 
    • Academy 
      • Training Overview 
      • Webinars 
    • Career 
      • Open Positions 
      • Your job at sepp.med 
    © 2026 sepp.med gmbh
    • Imprint
    • Data Protection
    • Contact
    • Cookies
    • Corporate Social Responsibility
    • AGB