Five Parallel AI Workflows in Regulated Manufacturing

The problem

Sixty percent of the manufacturer's products were classified as medical devices, which made MDR and ISO 13485 mandatory. Five separate processes — risk assessment, order intake, supplier management, sales research, and key account briefings — ran manually, disconnected from one another, and every one of them needed an auditable trail. Producing that audit trail by hand was the single largest time sink.

How we approached it

Rather than one large system, we designed five independent but coordinated workflows. We established which workflow would create the most value first and sequenced the build accordingly, because opening all five at once would have inflated both risk and delivery time for no gain. The decisive choice was on the regulatory side: MDR, ISO 13485, and GxP requirements were part of the first design decisions rather than a compliance layer bolted on later. In regulated manufacturing, deferring compliance usually means rewriting the system.

Outcome

• Risk Agent: dialogue-driven regulatory compliance assessment combining an LLM with RAG
• Email order automation: OCR on inbound email feeding orders straight into ERP
• Supplier scoring: reliability assessment with a KPI dashboard
• Lead generation: web scraping with personalised campaign generation
• Key account briefing: automatic pre-visit briefing preparation