Stay compliant. Faster.

Delivering innovative products with low time to market and complying with MDR, FDA and ISO are a challenge for many medical device companies.

Highstage replaces the traditional systems with a customizable digital management solution that simply documents and accelerates the pace of your work during development.

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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

Comtrol & simplicity

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

"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

Start accelerating today.

Get further with a customizable solution for medical devices.

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