Quality System Implementation

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:


In case there are no existing processes in place, we can also:
These engagements are typically performed based on an hourly charge, whereby we estimate in advance how many hours it would take for the activity.

PACS Regulatory FDA Consulting (Per Hour)

Price: $ 375.00   Add to Cart

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Specials

CIIP Study Guide - $120
HL7 Study Guide - $115
PACS Clinical Package - $550
PACS IT Package - $550

Training Schedule

AUG 2-5
DICOM On-line Certification Bootcamp

AUG 17
DICOM On-line Core Essentials

AUG 18
HL7 v2 FHIR On-line Core Essentials

AUG 23-25
PACS System Admin Online Cert. (PARCA CPSA) Bootcamp

OCT 5-6
PACS On-line Certification (PARCA CPAS) Bootcamp


Click here to view entire training schedule.

Tips & Tricks

Click here to view the latest video regarding the DICOM sniffer.
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