Phone: (940) 440-9791
Fax: (940) 580-2665
Email: sales@otechimg.com
Address:
215 E University Dr, Suite B
Denton, TX 76209-2011
USA
OTech is committed to making a difference in the lives of those that need us most. Click the image below for more information.
OT-DICE is an active DICOM test tool which is very simple to set up and operate, even with no special training.
PACS 510(k) Filing FDA and Quality Audit Quality System Implementation
PACS/RIS Consulting Connectivity Security (HIPAA and Cyber security)
Expert Witness for Legal Cases
Let our experts help get you up and running quicker and easier than trying to navigate the entire healthcare IT field by yourself.
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:
CIIP Study Guide - $135
HL7 Study Guide - $119
PACS Clinical Package - $595
PACS IT Package - $595
NOV 14-17
PACS System Administration
DEC 3
Module 1: DICOM Negotiation and Image Objects
DEC 4
Module 2: DICOM Communication Services and SR
DEC 5
Module 3: Image quality, DICOM Web and Troubleshooting
DEC 6
Module 4: Compression, Media, Conformance
FEB 25-26
Fundamentals of Clinical and IT (PARCA CPAS)
Click here to view entire training schedule.
Click here to view the latest video regarding the DICOM sniffer.
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