Quality

Standards & Processes

We have to meet the highest standards in everything that we do. From the development to the individual manufacturing processes up to the further handling of our products – all areas of work strictly comply with our quality management system. 

CorTec has implemented a comprehensive quality management system (QMS) according to DIN EN ISO 13485 (notified body: TÜV SÜD).

High process quality is maintained by continuous internal audits, staff training, and process improvements.

We have established several processes to support the consistency of our quality standards, compliance to the latest regulations, as well as continuous improvement of our  processes.

Our processes undergo detailed analyses of failures, modes, and effects (PFMEA).

Made in Germany.

CorTec is a young medtech company that was founded in Freiburg, Germany, in September 2010. All of our products are made here in Freiburg, Germany. 

ISO-Certified.

For CorTec quality comes first. We always aim to exceed our customers quality expectations.

CorTec is ISO 13485 certified.

Infrastructure.

All of our products are developed and manufactured in our ISO 14644-1 class 6 – 8 cleanrooms.

Certificates

You need more information about our quality policy and our certificates? Contact us:

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SPECIFICATIONS

FEATURE 

Recording channels 

Sampling rate 

Sampling dynamic range 

High pass filter cut-off 

Low pass filter cut-off 

Amplifier band pass gain 

Band pass roll-off 

Reference


Stimulation 

Stimulation channels 

Current 

Current source 

Pulse width 

Power supply 

Wireless data transmission 

Closed Loop latency

VALUE

32 

1 kHz 

16 bit (74 nV smallest increment) 

ca. 2 Hz 

325 Hz 

Adjustable: 100-750 

20 dB/dec 

Any (subset) of the recording channels selectable by software or one dedicated hard-wired additional contact 

Current-controlled, biphasic, rectangular, asymmetric stimulus pulses (cathodic amplitude with pulse width followed by an anodic counter pulse of 1/4x amplitude and 4x pulse width) 

 32 

Max. -6 mA / +1.5 mA (24 µA increments) within

 compliance voltage range of -11 V to +5 V 

Can be directed to any of the 32 electrode contacts 

Negative phase: 10 µs – 2,500 µs

Wireless inductive, 120-140 kHz

Bi-directional, radio frequency in 2400-2483.5 MHz band ≤ 40 ms