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Device Databases

This website provides extensive listings of medical devices. At present, Blood Pressure Monitors and Blood Glucose Meters are covered, however we will shortly be expanding to cover other device-types.

Validated Device Lists

Medaval provides lists of Validated Blood Pressure Monitors and Blood Glucose Meters, which are available freely for download via PDF. Please click below to download these PDF’s.

For Manufacturers

It is our hope that all the devices we list as certified, will carry the Medaval Certification Logo. The first set of devices to be assessed, under this process, are self measurement blood pressure monitors.

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Certificate of Accreditation

Medaval awards a Certificate of Accreditation to devices that have been proven to be accurate, for a particular function, according to a specified protocol. The validation is studied, not only for the results but also to ensure the protocol was followed correctly. Devices certified by Medaval can carry a Medaval Certification of accuracy, on its packaging, in its literature and in advertisements for that device for a period of time.

Medaval certifies the measurement technology, rather than the device itself. Therefore, it will soon provide a comparative-equivalence service whereby devices that share the same technology can also carry the certification.

Comparative Equivalence

  • Where a manufacturer incorporates identical technology in more than one device, Medaval can provide independent assessment of this claim via its Comparative-Equivalence service.
  • The Medaval Comparative-Equivalence process involves comparing every feature of the respective devices. Those features required for measurement technology must be identical.
  • Devices are then compared according to how they differ in other features, providing practical-use summary comparisons.
  • Comparative-Equivalence is independent of validation but, where a device is certified for a particular technology, that certification can be applied to all devices where that technology is proven to be identical.
  • Comparative–Equivalence is a full scientific study and the results are subjected to peer review.

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Assessment Reports

Medaval provides a comprehensive assessment of device validation studies carried out according to the most stringent protocols available at the time of validation.

For validation studies, all study details are assessed in order to ensure that the study was carried out in strict compliance with the protocol. It is only then that the study results can be considered valid. In keeping with scientific standards, the assumption (null hypothesis) must be that the study was not carried out in compliance with the protocol, unless proven otherwise. Therefore, omissions in the details required must be considered as being due to non-compliance.

For comparative-equivalence studies comprehensive details on core measurement, supplementary and accessory features are required for all devices being compared. In keeping with scientific standards, the assumption (null hypothesis) must be that the devices are unrelated, unless proven otherwise. As the devices must differ in some aspects, all differences must be described and proven not to be related to measurement accuracy.

Medaval provides comprehensive assessment reports on these studies including, where appropriate, the awarding of Medaval Certification. These reports can be purchased from Medaval at info@medaval.ie.

 

Validation Studies

We offer complete validation studies. We avail of a number of laboratories, taken from our Investigators Panel, that we blind pick to do the work independently. We undertake the arrangement & supervision. For more information, please contact us at info@medaval.ie.