We help drive organizational change
- in any industry

Medical device companies are subject to strict regulatory requirements. We help to ensure you meet these requirements by providing a way to track and manage the data and documentation for regulatory submission and approval. With Highstage, both you and your auditors will be smiling.
Track and manage product data throughout the development and production process to improve quality control and reduce the risk of defects or recalls. The increased control that Highstage provides can help reduce costs and improve profitability.

Streamline your product development process and reduce time to market. Highstage facilitates collaboration among teams and stakeholders to support communication and coordination. We also help you stay on top of security regulations and data privacy requirements.

For project- and process-oriented development teams, Highstage provides a centralized location for all data and information related to a project, making it easier to manage the documents, part and communication made through all stages of a project. Manage the entire lifecycle of a project from planning to delivery and keep track of aftermarket and field service, more efficiently, effectively and with less errors.

Highstage configurations

Whether you work in a start up or larger enterprise, we have a solution for everyone.
The Highstage modules can be mixed and matched in various ways depending on your needs.
Document Management System
* Requires the Document module
Gain full control of revisions
Easily manage review and approval processes
Locate any document with a single search term
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Quality Management System
* Requires the Document module
* Recommended with the Action module for process workflow management
Manage Quality/HSE policies
Get an overview of procedures and flowcharts
Implement a live non-conformity system with the Action module
Book a demo
Product Data Management
* Requires the Part module and Document module
Structure release processes
Manage products, components and variants
Define and maintain product assemblies
Comprehensive documentation export
Independent PDM, but integratable with any ECAD/MCAD tool
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Product Lifecycle Management
* Requires the Part module, Document module and Action module
* Recommended with the Device module for ERP/MRP integration and device traceability
Includes all modules for one complete corporate management system
Submit documents to suppliers via the built-in mail journalling system
Manage customer complaints
Revise and rebuild development processes
Build complete and comprehensive life cycle history for each product, parts and components
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Meet a client

How Develco Products conquered BOM hell

Uneeg Medical has got a steel grip on their technical files

Uneeg uses Highstage across their development projects. Documents are electronically signed by reviewers and approvers, according to FDA CFR Part 11 requirements. Nita Volder Hansen – Process Engineer at Uneeg – is a big fan of references, and for a good reason – references in Highstage are used to manage which revision is correct and valid. Using the Reference Lock functionality, a revision can be locked to the DHF even if newer versions exist.

Nita Volder Hansen
Process Engineer at Uneeg

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We are PLM experts and are happy to guide you on your journey.

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