QMR, LLC - Quality Management Resources

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info@qmr-llc.com
760-451-6306
fallbrook, CA

DEVICE/DIAGNOSTIC SUBMISSIONS EXPERIENCE


Johnson & Johnson Sterile Design Division 

Approximately fifteen 510(k) submissions for custom sterile procedure packs and cardiopulmonary blood reservoir.


White Knight Health Care 

Approximately ten 510(k) submissions for custom sterile procedure packs and a variety of sterile and non-sterile reusables and disposables.


Wyndgate Technologies 

One 510(k) submission for stand alone blood bank software.


Mediware Information Systems 

One 510(k) submission for stand alone blood bank software.


Quality Management Resources

Almost four years involvement in pre-IDE meetings and in developing PMAA for a non-invasive blood glucose monitor (PMAA never filed, device still under development).

Three 510(k) submissions for radiology imaging systems.

Three 510(k) submissions for stand alone blood bank software.

Two 510(k) submissions for drugs of abuse test kits.

Two 510(k) submissions for home use medical device telemetry devices.

One 510(k) submission for a power assisted hospital stretcher.

One 510(k) submission for dental materials.

One 510(k) submission for cardiac monitoring reference tool (software).

Ten MDDS device classification assessments.

Ten device classification assessments.

Three pre-IDE requests.

One de novo petition.
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