Rematiq
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For Medical Device Companies

Not retrofitted for regulation. Engineered for it.

The purpose-built AI system for medical device companies, applying systems engineering rigor across functions to automate documentation, prove compliance, accelerate time-to-market, and stay audit-ready every day.

The frameworks you live in

Handling the complexity other systems can’t handle.

  • Deploying AI in medical devices has unique requirements towards data complexity, audibility, accuracy, and change control. REMATIQ masters it all.
  • 01

    From reactive to continuous compliance. Ensure compliance against global requirements at each stage of the lifecycle for faster approvals and airtight audits.

  • 02

    Documentation on autopilot. Over 50% of R&D team’s time is spend to documenting. Win back innovation potential by generating all your device documentation in REMATIQ.

  • 03

    Agility across the company. Faster releases, higher adaptability, streamlined change management in products and processes across the full organisation.

  • 04

    Master complexity. Built in traceability, versioning, and de-composition handles the complexity of the most complex global R&D programs.

Use Cases

Built for companies that can’t afford loose ends.

The bottleneck isn’t building the product. It’s proving that every requirement, decision, test, process, and record still holds together, before launch, after launch, and every time something changes.
Regulatory Intelligence

Regulatory Intelligence.

AI identifies all applicable regulatory requirements and checks your documentation for gaps in real-time.
Requirements Management

Requirements Management.

Extract, structure, de-compose, trace and correctly formulate any requirement across your products and systems.
Document Generation

Document Generation.

Create any document with a click of a button. Compliant with all requirements. Following your internal guides.
Compliance Check

Compliance Check.

Ensure compliance of any deliverable in your company against global applicable requirements.
Submission Generation

Submission Generation.

Create any document for a dossier with a click of a button. Compliant with all requirements. Following your internal guides.
Traceability Graph

Traceability Graph.

Automatically link extracted data objects of any regulation, process, test or product documentation to easily facilitate change management and migrations.
Already in production

Running in production at the world's largest medical device manufa

The efficiency gains aren't projections from a deck. They're what R&D leaders at Philips, Bayer and B. Braun are reporting back from production deployments.
R&D

Ship products. Not paperwork.

REMATIQ automates documentation, ensures compliance and ensures R&D projects stay on time.

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Regulatory Affairs

Defensible by default.

From regulatory intelligence to design control and submissions, REMATIQ automates the work that proves a product is ready. Keep timelines, demonstrate compliance, pass every audit.

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Quality Management

Audit-ready. Always.

Quality teams keep documentation continuously compliant, so inspections and audits no longer trigger weeks of scramble before every review.

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The medtech lifecycle, on REMATIQ

One AI system from idea to launch and post-market.

REMATIQ doesn’t replace your PLM, ALM, or eQMS. It connects the work between and inside them, automating documentation, preserving traceability, and keeping every requirement, decision, and deliverable compliant at every stage.

Talk to an AI specialist.

Kim Bergstrand

Head of Sales

Book a 30 min call

  1. 01

    Requirements. Regulations and any other inputs on the left side of the V-model become structured requirements - de-composed to the right level and linked to the source.

  2. 02

    Design controls and V&V. Design inputs, outputs and tests stay linked and traced with requirements. Change something upstream, see the impact downstream. Check every deliverable for compliance.

  3. 03

    Regulatory submissions. Technical documentation and packets assembled from the same source. Generated by AI, checked for compliance against global requirements.

  4. 04

    Post-market surveillance. Collected data and regulatory updates feed back into the same graph, accessible by the same agents.

If your team spends more time formatting than building, we should talk.

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