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 - $135
HL7 Study Guide - $115
PACS Clinical Package - $595
PACS IT Package - $595
SEP 3
Digital and Computational Pathology
SEP 7
PACS On-line Core Essentials
SEP 8
HL7 v2 On-line Core Essentials
SEP 9
DICOM On-line Core Essentials
SEP 10
HL7 FHIR On-line Core Essentials
SEP 14-15
PACS On-line Certification (PARCA CPAS) Bootcamp
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