Development, manufacturing and distribution of medical devices for electrophysiological diagnostics
EMS Handels Gesellschaft m.b.H.
Korneuburg, AustriaNew on Amplifa
About EMS Biomedical
EMS Handels Gesellschaft m.b.H. (EMS Biomedical), based in Korneuburg, Austria, develops, manufactures and markets medical devices for electrophysiological diagnostics. The product portfolio includes systems for electromyography and evoked potentials (EMG/EP), electroencephalography (EEG), neuro-monitoring in intensive care units (ICU/NICU), cerebral function monitoring (CFM), polysomnography (PSG), evoked potentials (ERP), ambulatory and long-term EEG (AEEG, LTM, cEEG), intraoperative monitoring (IOM), Electrical Impedance Segmentography (EIS) as well as a complete range of electrodes and accessories. Manufacturing takes place at the headquarters in Korneuburg, where development and distribution are also located. The core competence is electronic engineering, in particular the design of amplifiers; the company covers design, development, production, service and marketing across the entire value chain. Quality management and regulatory affairs are covered by an EU QMS certification under the MDR, which is audited by the Notified Body EC International (NB 2265).
- Site
- Korneuburg
- Processes
- Design, development and manufacturing of medical devices (electrophysiological diagnostics: EMG/EP,, Electronic engineering / amplifier design, Development and manufacturing of medical devices, Servicing/Support, Marketing, Complete range of electrodes and accessories
- Certificates
- EU QMS Certificate (MDR)
- Founded
- 1986
- Industries
- Medical Technology, Electrophysiological Diagnostics, Neurology/Neurophysiology, Intensive Care Medicine (ICU/NICU), Sleep Medicine (PSG), Intraoperative Monitoring
- 01
Design and Development
- 02
Electronic Engineering (Amplifier Design)
- 03
Manufacturing/Assembly
- 04
Quality Management and Regulatory Affairs
- 05
Service and Support
- 06
Marketing and Distribution
Locations
Korneuburg
ATHeadquarters: Development, Production, Distribution
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Design, development and manufacturing of medical devices (electrophysiological diagnostics: EMG/EP,Assembly | – | – | – | – | – |
| Electronic engineering / amplifier designEngineering | – | – | – | – | – |
Additional services
Quality and Certification
The quality management system is certified under the EU Medical Device Regulation (MDR); certificates 2024-MDR/QS-030 (EEG Sienna/Sienna Ultimate) and 2025-MDR/QS-055 (EMG/EP Surpass/Surpass LT) from the Notified Body EC International, NB 2265.
| Evidence | Korneuburg |
|---|---|
| EU QMS Certificate (MDR) |
Company History
- 1986
Company registration (FN 72048d, Regional Court Korneuburg)
- 1989
Ruzena Ortnerova joins the company (today COO)
- 2009
Paul Spooner joins as Commercial Director
- 2024
EU QMS certificate 2024-MDR/QS-030 issued for Sienna/Sienna Ultimate
- 2025
EU QMS certificate 2025-MDR/QS-055 issued for Surpass/Surpass LT