Our Goal

Efficient support for developing safe medical devices

Consulting & Planning

We guide manufacturers through the life cycle stages of medical devices, assuring to meet regulatory requirements

Design & Development

We provide development support in form of simulations, mechanical engineering & design – from concept creation to serial production

How we operate

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    Free personal consultation

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Areas of expertise

Starting in the automotive sector, we then specialized on medical device industry for which we offer a broad spectrum of support.

We deliver the of services needed to place medical devices on the market.

Regulatory Affairs

Advisory about legal requirements for medical devices and guidance for setting up technical files…

Requirements Engineering

Reducing unnecessary workload with precise requirements engineering…

Design & CAD Modelling

Concepts, design drafts, CAD models, renderings, prototypes, detailed construction suitable for production…

Quality Management

Quality management for medical device manufacturers as a solid basis for efficient workflows…

Risk

Management

Planning of risk management activities, documentation, moderation of risk assessment and risk control…

Usability Engineering

Planning and implementation of usability activities, documentation in an usability file…

Simulation

Strength simulations, steady-state and transient flow simulations, electromagnetic and thermal simulations…

User Manual

Layouting user manuals and identification of required symbols to be applied to medical devices…

Geoinformatics

Manipulation of georeferenced vector and raster data using qgis® & postgis®…

We are a reliable partner in the field of medical devices – we don’t just talk, we do!

If you want to be supported by an experienced engineering office, then do not hesitate to contact us!