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Medical Devices & Healthcare

Run manufacturing, quality and traceability without losing compliance or control.

When your production is regulated, every lot, every check and every change has to be on record.

Centralise manufacturing, quality, documentation and traceability in a single system to comply with regulations, reduce risk and scale with more operational control.

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ISO 13485
MDR
FDA 21 CFR 820
UDI
Lots in production 47
12%
Quality checks today 128
logged
Open non-conformities 3
2 this week

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If this sounds familiar, ForgeFlow Cloud is for you.

Scattered traceability
Slow audits
Quality outside production
Non-conformities hard to manage
Too much manual documentation
Poorly controlled production changes
Real costs unknown
Misaligned teams


Growing shouldn't make your quality processes more complex, or put regulatory compliance at risk.

We understand your day-to-day

Manufacturing medical devices means much more than producing. Every lot has to be fully traceable, every quality check recorded, every change documented, and all the evidence ready for an audit.

As the company grows, manual processes, spreadsheets and disconnected systems stop being sustainable and increase operational risk.

The apps we set up for you

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Capabilities built for how you work

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The problems that hold growth back

When processes aren't connected, every new regulatory requirement adds more complexity and more risk.
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A foundation built to manufacture with control and stay compliant

We help you bring manufacturing, quality, inventory and documentation together in a single platform built for regulated environments, so compliance stops being a separate effort.

We do not just implement an ERP. We analyse how your manufacturing actually works and adapt the solution to your process, so traceability, document control and quality are part of your daily operation.

Full lot traceability
Quality inside production
Controlled documentation
Audit-ready evidence

How a regulated manufacturer connected production, quality and traceability

Planning, batch manufacturing, quality checks, documentation and lot release in a single connected flow.

Success Stories

Companies that have already made the leap

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What improves when manufacturing and quality run on the same system

Full traceability by lot and serial
Less time preparing audits
Fewer non-conformities
Shorter manufacturing lead time
Real cost per unit
Reliable information across departments

“ForgeFlow offers a unique combination of excellent technical expertise and being able to understand what we’re trying to do in areas such as inventory management, finance and accounting or shop floor control.”

Christian S. Eversull, MD · Co-Founder and Principal, AuST Group


Is your manufacturing process ready to keep growing?

Tell us how you currently manage manufacturing, quality and traceability. We will look at your context and show you how an integrated operation could work for your process.

Try the demo

Contact us