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OUR QUALITY

Our team of ECG technicians and cardiologists follow strict procedures. Want to know more about our approach?

PROCEDURES AND CERTIFICATIONS

Our team of ECG technicians and cardiologists follow strict procedures. This guarantees the high quality of our ECG reports. To ensure the safety and reliability of our full-service provision and especially patient privacy, information security is of the utmost importance. Therefore, we are ISO 27001 (certificate) and and NEN 7510 (certificate) certified. 

In addition, according to European regulations (MDR), a number of product parts of our services are qualified as medical devices. Examples include patient holters and the software in our analytics center. On request, we will be happy to send you our declarations of conformity, certificates of medical products and accessories that we supply or our ISO 13485 certificate* of the quality management system. 

SAFETY

The data from the patient's ECG and diary is sent to our analysis centre in a highly secure manner, where it is stored and processed.

VALIDATION

Our analysts review and validate the results. They complete the report with their analysis of rhythm strips relevant to the healthcare provider. 

CHECK

The report is then checked by an experienced ECG supervisor and the final report is generated.

PROCESSING

Our data entry team reviews the data and uses our analysis program to process it.

ALGORITHM

The algorithm we developed determines the RR interval and classifies possible rhythm and/or conduction disturbances. 

REPORT

You receive the report within the agreed time via a secure connection. In urgent situations, this can often be within 30 minutes. 

HOLTER REPORTS SPECIFICATIONS

EVENT REPORTS SPECIFICATIONS

We work with sensitive patient information. We therefore consider information security to be of the utmost importance. Fysiologic ECG Services is ISO 27001 and NEN 7510 certified. View our BSI registrations.
*In addition, the Systolé Hardware business unit is ISO 13485 certified, the quality system for medical devices. View our TÜV Rheinland registration.