The implementation of a quality system is a requirement for any manufacturer of medical devices in the US, regardless of its classification, i.e. whether it needs a 510(k) filing or not. The specific requirements for these systems are defined by the FDA in the form of the QSR (Quality System Ruling). These rules are similar to what is used by the ISO quality system standard, however, with some additional processes and procedures, mainly in the area of complaint handling.
OTech has assisted with the implementation of the QSR quality systems. This implementation is highly customized and depends on what the vendor has in place. It can consist of either a review, for example:
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CIIP Study Guide - $120
HL7 Study Guide - $115
PACS Clinical Package - $550
PACS IT Package - $550
FEB 8-10
Comprehensive DICOM Certification
FEB 11-12
Comprehensive HL7: V2 and FHIR
FEB 22
PACS On-line Core Essentials
FEB 23
DICOM On-line Core Essentials
FEB 24
HL7 v2 On-line Core Essentials
FEB 25
HL7 FHIR On-line Core Essentials
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