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Customizable digital management solution.

Replace the traditional systems with a customizable digital management solution that simply documents and accelerates the pace of your work during development within the medical device industry.

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Let's improve your efficiency

Customizable processes

Compared to competitors, Highstage is priced making even small companies able to utilize the benefit of managing their development in a professional and structured way.

Fast implementation

Fast and easy implementation allowing you to speed up the process within 4-6 weeks.

Audit ready

Regulatory ISO/audits are welcome at any time, as normally no 'clearn up' is necessary

Control & simplicity

Every solution is designed to provide full overview for the managers and create simple workflows for the stall.

Medical device companies partnering with Highstage

And 7 more benefits/featuresChevron icon

Configurations

The various Highstage modules can be used in a variety of combinations, depending on which business processes you want to improve. From the simplest document control system, to the corporate wide, full fledged, PLM System

DMS

Document Management System

Manage documents with revisions, review/approval workflow and automated content.

Requires 

  • Document module
QMS

Quality Management System

Manage Quality/HSE policies, procedures and flowcharts. Implement a live NON-conformity system (with Action Module)

Requires 

  • Document module
  • Action module (optional: for process workflow management)
PDM

Product Data Management

Manage products and components. Structure the release process and manage variants. Involve supply chain.

Requires 

  • Part Module
  • Document module
PLM

Product Lifecycle Management

Manage customer complaints, change and development processes. Build life cycle history on delivered units.

Requires 

  • Part module
  • Document module
  • Action module
  • Device module (optional)

 

 

 

Get demo or want to talk?

Get further with a customizable solution for medical devices. Fill out the form and we will get in touch.

"The argument that you don't have the time to implement Highstage and understand the values that form the platform, is something that needs to be challenged. It is without a doubt the best management system on the market"

Claus Dall Hansen

Interim CEO

6 HOWs On why Highstage works for you

Highstage offers a solution that literally helps you at any stage of your work with medical device compliance. Based on smart digital modules that seamlessly fit together, we focus on your needs for future-proof agility.

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  1. Compliance is made faster through a completely new level of usability.
  2. Tech files are automatically generated and make work simpler and more flawless
  3. Automatic reports compile and reduce the work maintaining DHF/DMR indexes to a minimum
  4. Safe signatures are standard and can for medical device applications even be forced to adhere to FDA CFR Part 11
  5. Traceability is essential at all times; thus, all operations are recorded in the eventlog
  6. Document mapping lets you gain full control over the project by monitoring the status of the documents in the document map

Resources

You are more than welcome to contact our main office. But if more convenient, please contact one of these local partners.

Denmark: AL Engineering

Tina Linders

+45 29 13 24 45

tina@al-engineering.dk

Norway: Cenit Consulting

Eirik Lima

+47 982 96 599

eirik.lima@cenitconsulting.com

Denmark: Transmedical Alliance

Gert Andersen

+45 23 60 06 50

gert@transmedicalalliance.com