Services
We cover two branches under one quality system. As a catalyst we provide consulting, medical device quality engineering and regulatory affairs, including outsourced design and development support. As a design partner we develop the mechanical, electrical and software aspects of medical devices. The same people write the evidence and build the device, so the technical file matches what is inside it.
Consulting · quality engineering and regulatory affairs
Design · engineering beside you
Where we are strong
Our specialities are the hard combinations: the disciplines that have to hold together at once.
Connected & home-care devices
Home use is the hardest usability environment: the 3 a.m. dose, the grandparent, the alarm nobody hears. Software, connectivity and usability evidence that fits together.
Energy-based therapies
PEMF, photobiomodulation and medical gases: electrical safety, gas-pathway biocompatibility and clinical evidence that has to stand as one argument.
AI-enabled products
Machine learning inside the software life cycle: data quality, bias, robustness and the clinical evaluation path for AI software.
Team & quality system
Beebrox is a medical device R&D and consulting company, founded in 2019 by Boštjan Barbiš, medical engineer. We work for legal manufacturers across the EU, in English and Slovenian.
Our quality management system is certified to ISO 13485:2016 by SIQ Ljubljana: certificate M-194, first issued 2021-05-31, current issue 04 of 2026-06-04, valid until 2029-08-31. The certified scope:
Provision of consulting, medical device quality engineering and regulatory affairs services, including outsourced design and development support for medical devices performed for legal manufacturers.
Development of mechanical, electrical and SW aspects of Active and Non-active, Non-implantable, Non-sterile medical devices.
Contact
Tell us about your device: where you are in the design and development process, which standard families are involved, and what evidence you need.