Medical devices

Simplify the complexity of your medical device development

Stay ahead of regulatory demands, streamline quality processes, and be ready for audits any time with our integrated platform.

Loved by regulatory experts everywhere

Complete control

Full control
over tech-files

Rest assured knowing your documents are always secure, accessible, and clearly organised. Instantly see whether you’re working with the latest version - no second-guessing needed.

Create your DMRs and DHFs effortlessly as you and your team tackle day-to-day tasks.

Stay in complete control of your tech files with our robust reference structure. Every change is tracked, and persistent copies ensure full traceability when you need it most.

  • Document
    structures
  • Revision
    management
Seamlessly integrated

Integrated document management

With Highstage, any data can flow directly into a live Microsoft Office document—automatically. From formatting and font sizes to layout and positioning, Highstage can even create documents from scratch.

Let Highstage handle the heavy lifting: automate in-document revision logs, referenced part lists, and author lists with ease. Need version numbers, approver names, or other details added to PDFs like drawings or datasheets? Highstage has you covered.

Stay safe and compliant with FDA CFR 21 Part 11 signatures—available for any Highstage item.

  • Part 11
    signatures
  • Content
    sync
Empower Employees

Comprehensive
compliance management

Easily manage training matrices and access historical competency reports by role, employee, or procedure—all in one place.

Gain a clear, organisation-wide view of competency status. Empower employees with a detailed overview of their skills and quick, easy access to training resources.

  • Competence
    management
  • Training
    traceability

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.“