Medical devices

Peace of mind for Medical Device companies

At Highstage, we’re all about empowering medical device companies to succeed. We don’t just stop at traditional PLM or QMS solutions – we go further, equipping you with the tools to create and drive top-performing medical device companies.

Loved by regulatory experts everywhere

Complete control

Buit for Medtech

At its heart, Highstage integrates everything you need to streamline
your operations into one unified system:

• Document management with FDA Part 11

• Revision control and Audit trails

• Process management

• Parts and BOM (Bill of Materials) management


By tailoring these features to your needs, we make it easy
to optimise your design-to-manufacture processes:

• Gain effortless control over technical files and docs

• Be audit-ready at any time

• Intuitive Product and BOM (Bill of Materials)

• Simple product development and change control

• Synchronize product design data and documentation

• Integrated quality management for compliance

  • Document
    structures
  • Revision
    management
Seamlessly integrated

Why Highstage is Different

Highstage is more than a PLM, QMS, or DMS—it’s a flexible, scalable management system. Start small to control documents, streamline audits, or solve key challenges, and scale as you grow.

Our modular approach means you only take what you need, when you need it. And because Highstage can be deployed in days, you’ll see value almost instantly.

As your needs grow, you can turn on additional features or expand capabilities, all without needing to switch platforms.

The result? A faster start, a perfect fit for your business, and maximum value, sooner.

  • Part 11
    signatures
  • Content
    sync
Empower Employees

Built for Everyone

We believe in simplicity with purpose. With Highstage, you enter data once, in a logical context, and it works for everyone, whether you’re the CEO, compliance officer, project manager, engineer, or in procurement.

  • Competence
    management
  • Training
    traceability
End‑to‑End Quality

And Beyond….

  • Supplier qualification and management 

  • Non-conformity and CAPA management

  • Material and Assembly traceability

  • Design control guidance

  • Design Control guidance

  • Audit management

  • Design reviews

  • Post-market activities

  • Risk Management

So easy to use,
it's actually loved.

Our solutions is built around your business needs. Enabling you to focus on what actually matters - letting you focus on your business, not your document structure.

Tidewave

When compliance is mandatory

“Compliance is non-negotiable in our industry, and Highstage has made it significantly easier to maintain.“

The importance of a single source of truth

"Highstage has become an essential tool for maintaining a single source of truth and ensuring seamless cross-departmental collaboration."

Better business through better control

“The impact of Highstage on our business operations has been profound. Our processes have now become smoother and significantly faster.“