Medical devices

Traceability has a key role in the monitoring, supervision, and improvement of the overall quality of medical devices and in-vitro devices.

Track your Medical Device up to your end customer

Traceability has a key role in the monitoring, supervision, and improvement of the overall quality of medical devices and in-vitro devices

 

Serialization, by assigning a unique serial number to a medical device despite its manufacturing origin around the world, is the first step for a traceability solution.

udi on medical devices

Get a Global picture of traceability for medical devices worldwide

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Enhanced traceability from Manufacturers to Patients

Track and Trace solution enables wide-scale benefits starting from the plant level up to the end customer – the patient.

 

The unique serial number provides tracking of any medical devices and makes the monitoring process easy to be followed. The implementation of traceability solutions will also improve the management of returnable medical devices.

 

Another benefit of tracking the handling and transportation data (temperature, humidity) of sensitive medical devices, the responsibility of mishandling can be easily determined.

 

Serialization and aggregation as part of end-to-end traceability will reduce the risks of recalls. by limiting to the exact number of serial numbers rather than whole batches.

Compliance with the new EU MDR and IVDR

Ultimate Compliance Test

    Your name:
    Your email address:

    What is your role as economic operator?

    What is the approximate annual volume of devices manufactured?

    Which is the class of your medical device (MD) or in-vitro diagnostic device (IVD)?

    Are the devices active implantable?:

    Is your medical device reusable?

    Target Market?

    Please list specific countries:

    What is your shipment unit?

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