AMEDTEC Medizintechnik Aue GmbH

Medical Technology from Saxony: Diagnostic Systems and Data Management

AMEDTEC Medizintechnik Aue GmbH was founded in 1998 and develops, manufactures and distributes devices and software for cardiovascular diagnostics. The product range includes 12-channel resting and exercise ECGs, long-term ECGs, blood pressure monitoring, ergospirometry, body plethysmography and spirometry. The core element is the company's own data management system AMEDTEC ECGpro, which is integrated into hospital IT and practice environments via HL7, DICOM and GDT interfaces and enables data acquisition, analysis and exchange of all examinations. AMEDTEC was one of the first providers worldwide with wireless Bluetooth transmission of 12-channel ECG recordings; the CardioPart 12 WLAN system transmits wirelessly via WLAN. In addition to its own product line, the company works as a development service provider for hardware and software of ECG systems for international manufacturers (OEM). In cooperation with Geratherm Respiratory, the complete product range for cardiopulmonary function diagnostics is offered. Manufacturing and service with maintenance contracts, hotline, remote maintenance, repair and STK/MTK checks are located at the headquarters in Aue (Saxony); offices exist in Bad Neustadt a.d.Saale and Bergisch Gladbach. Since November 2019, AMEDTEC has been part of the Swedish Cardiolex Group.

Site

Aue

Processes

Development, manufacturing, production, service and sales of devices and software for, Cardiovascular diagnostic devices and software (development, manufacturing, service, sales), ECG data management system ECGpro (HL7, DICOM, GDT), OEM development of hardware and software for ECG systems, Service: maintenance contracts, hotline, remote maintenance (TeamViewer), repair, STK/MTK, Loaner devices during repair

Materials

ECG data management system (software), Wireless transmission technology

Certificates

DIN EN ISO 13485:2021-12, MDD 93/42/EEC Annex II quality assurance system, ISO 13485, MDD 93/42/EEC Annex II, MDR application (EU 2017/745)

Founded

1998

Industries

Medical technology, Cardiology, Pulmonology, Hospitals, Physician practices/medical centers

1. 01

   Development (hardware and software)

2. 02

   Manufacturing

3. 03

   Quality inspection

4. 04

   Sales

5. 05

   Service (maintenance, repair, STK/MTK)

Processes and Technologies

Locations

Aue

DE

Headquarters: development, production, service, sales

Bad Neustadt a.d.Saale

DE

Branch office

Bergisch Gladbach

DE

Office

Products and Systems

Inside the production

Processes & technical limits

Certificates and Quality Assurance

The quality management system is certified according to DIN EN ISO 13485:2021-12 (certificate 110922M8A, valid until 17.09.2027). Service technicians are authorized in accordance with DIN EN 62353 and perform STK/MTK checks.

History

1. ~1970er

   Beginnings with the design of a 6-channel electrocardiograph; Saxon measurement and medical technology becomes known worldwide.

2. 1998

   Foundation of AMEDTEC Medizintechnik Aue GmbH.

3. 2006

   Positioning as a provider of holistic solutions; market launch of the company's own system AMEDTEC ECGpro; one of the first providers worldwide with wireless Bluetooth transmission of 12-channel ECG.

4. 2007

   Independent market entry with own product line; establishment of sales, application support and service.

5. 2019

   Since 1 November 2019, AMEDTEC has been a member of the Cardiolex Group (Sweden); the group also includes Cardiolex and the suction unit manufacturer Strässle.