Experience with regulatory systems, notified bodies and documentation is of the essence when developing healthcare technology. Our clients choose us for our ability to combine that experience with creativity and fast track development.

Clients

It is my pleasure to inform you that the first prerolled TachoSil fleeces were sold in Austria (following successful approval in the European Union and production of first full batches here in Linz)! Launch preparation in the other countries is ongoing. Let me take this opportunity to thank you and the entire team at Kapacitet once more for your excellent and hard work.

— Dagmar Stimmeder, Associate Director Product Management, Takeda

Squint-Scope

Squint-Scope is an angled mini-periscope making it easy to examin squinting eyes, particularly on small children.

Applied services

  • Mechanical development from idea to finished product
  • Mainly 3D-printed
  • Small scale manufacture

Takeda

For the production of a haemostatic device we have conceptualized, developed, installed and qualified a custom designed production line.

Applied services

  • From product idea to operational qualification (OQ)
  • Limited production for stability studies in in-house controlled environment 
  • Installation in Austria
  • Scheduled service and maintenance

Acarix

Together with Acarix we have developed and produced a medical device for estimating the risk of suffering from coronary artery disease.

Classification

  • Medical device class 2B

Applied services

  • Concept development
  • Mechanical development
  • 2D documentation
  • Production of all parts
  • In-house assembly of 50 devices for clinical tests
  • Sourcing related to scale up production at EMS
  • TÜV approved as a critical supplier

NNE Pharmaplan

To enable NNE to optimize a pharmaceutical production line, we have developed a stand-alone machine that replicates and measures parameters of the line.

Applied services

  • Concept development
  • Engineering
  • Delivery of 2 machines
  • CE marking

Delta ePatch

Alongside the HW/SW team at Delta we developed the mechanical design of a body-worn patch sensor and produced CE approved devices for clinical trials.

Applied services

  • Concept development
  • Design for manufacturing
  • Flexible production for clinical trials (+2.000 pcs)

Urox

Urox Night improves life quality for incontinent men. Together with industrial designers we have developed and engineered this patented product.

Applied services

  • Technical concept development
  • Mockup and test of critical features
  • Design for manufacturing
  • 0-series production

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Sonion

Together with the team at Sonion we developed a handheld, vacuum-assisted breast biopsy device with Single Insertion, Multiple Sample (SIMS) technology.

Applied services

  • Mechanical development from concept to final production
  • Production documentation
  • Validation of molded parts – 3D scanning
  • Tolerance analysis

Coloplast

Together with the team at Coloplast we developed and took part of the project management in the development of SpeediCath, an instantly ready to use catheter.

Applied services

  • Technical project management
  • Product development

Coloplast

Concept and product development of a transanal irrigation system for people who suffer from faecal incontinence and constipation.

Applied services

  • Concept development
  • Prototype development
  • Design for manufacturing
  • Limited production for marketing tests

Scanflex

We have developed a range of height adjustable frames for disabled, schools and elderly people. Knock-down concept, easy to install, robust, affordable.

Applied services

  • Technical concept development
  • Design for manufacturing
  • Series production and product support

Medema

In a joint cooperation with Medema we have developed the cabin of an electric scooter.

Applied services

  • Concept development
  • Prototype development
  • Engineering
  • Production documentation

Medema

Together with Medema we developed a height adjustable footrest with compensating leg support for an electric wheel chair.

Applied services

  • Concept development
  • Mechanical development
  • Production documentation
  • Functional prototype (look like/works like)