AI Technology for Medical Technology

Our solutions for your digital transformation

Prompt & Workflow Hub

Proven AI building blocks for all regulatory processes

What makes it special: We don't just use prompts, but also structured data and ontologies. Because LLMs are increasingly becoming "Ontology Wrappers" - only with structured data do you get reproducible, complete, and correct results.

Supported Processes

Development

From requirements analysis to design verification

Approval

Technical documentation and conformity assessments

Clinical Evaluation

Clinical Evaluation Reports and literature analyses

Post-Market Surveillance

Market monitoring and vigilance processes

The 3 Activity Classes of Our Prompts

Generate ideas, collect data

Creative support in brainstorming and systematic data collection

Generate additional data and documents from data

Transformation and enrichment of existing information

Review, evaluate, summarize, convert documents

Quality assurance and intelligent document processing

Concrete Examples

  • Check intended use for completeness
  • Create a PHA (Preliminary Hazard Analysis)
  • Design a software architecture
  • Develop a power supply concept
  • Compile stakeholder and product requirements
  • Create and complete GSPR checklist

Always Up to Date

Our prompts are continuously adapted to regulatory and technological changes.

Request Demo

AI Infrastructure

GDPR-compliant AI models without IT projects

Data Protection Guaranteed

GDPR-compliant environment - your company data stays with you

Start Immediately

No IT projects, no dependencies - get started right away

Multi-Model Access

Test different AI models and choose the best one

Full Cost Control

Transparent billing without hidden license costs

Our Service Models

Do it WITH you

We help you build your own infrastructure

Do it FOR you

We build your individual infrastructure

Infrastructure as a Service

Ready to use - our main offering!

Your Benefits at a Glance:
  • No complex IT projects
  • No own IT resources required
  • Save on individual licenses from OpenAI, Anthropic & Co.
  • New models are automatically integrated
  • 100% IP protection and data security

Enterprise Platform

The end-to-end data platform for regulatory excellence

System Architecture
Enterprise Platform Architecture

The platform integrates all regulatory-relevant data flows

Core Components

AI-driven Requirements Extraction

Automatic identification of relevant regulatory requirements

Hierarchical Data Structuring

Goal → Domain → Area → Requirement

Seamless Integration

PLM/ALM systems, authority databases, Notified Bodies

Intelligent Document Generation

AI-based creation of approval documents

Integrated RegTech Tools

Regulatory Radar

Automatic monitoring of regulatory changes

Already integrated
Post-Market Radar

AI-supported market monitoring and vigilance

Already integrated
What Makes This Platform Unique?
  • End-to-end integration of all regulatory processes
  • Structured data processing with ontologies
  • Integration of external sources (FDA MAUDE, NIST, PubMed)
  • Direct connection to authorities and Notified Bodies
  • AI support for all critical tasks

Innovation Lab

Shaping your AI future together

Joint Development

We work side by side on your processes

Compliance Guarantee

Always compliant with standards and laws

Quick Wins

Focus on your tasks - we clear obstacles out of the way

How It Works

1. We bring:
  • Regulatory expert knowledge
  • Structured data and proven prompts
  • Secure AI infrastructure
2. We work like a Scrum Master:
  • Continuously remove your obstacles
  • Ensure fast iterations
  • Keep focus on your goals
3. We take care of:
  • Validation of jointly developed AI tools
  • Ensuring "AI Literacy" in your team
  • Documentation for audits and approval

Perfect for:

  • • Pilot projects
  • • Process automation
  • • Quality improvement
  • • Acceleration
Request Innovation Lab

Which Solution Is Right for You?

Our experts are happy to advise you on your selection

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