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: $ 300.00   Add to Cart

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Specials

CIIP Study Guide - $135
HL7 Study Guide - $115
PACS Clinical Package - $595
PACS IT Package - $595

Training Schedule

FEB 10
PACS On-line Core Essentials

FEB 11
HL7 v2 On-line Core Essentials

FEB 12
DICOM On-line Core Essentials

FEB 13
HL7 FHIR On-line Core Essentials

MAR 23-24
Fundamentals of Clinical and IT (PARCA CPAS)

MAR 25-28
PACS System Administration


Click here to view entire training schedule.

Tips & Tricks

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