Each of our associates has more than 15 years experience in the medical imaging and information field. We can provide advice on regulatory and quality topics including 510(k) filings, quality system implementations, federal regulations for medical device manufacturers for both US (FDA) and Canada, compliance and implementation of new FDA design controls. In addition, we provide consulting on connectivity including DICOM, HL7 and IHE, as well as network security implementations applicable for healthcare institutions.
Each medical device in the US, which is classified as a Class II, which includes PACS systems, requires the manufacturer to register its site, their products and to have a quality system in place meeting according to the so-called Quality System Rule (QSR), which used to be called GMP. In addition, they are required to file with the FDA a set of documents aka 510(k), to get clearance for selling their product. OTech can assist you with the preparation and filing process. Click for details.
We have performed several audits of manufacturers, who either want to assess their FDA or Quality System compliance as part of their risk management process, or who are suddenly faced with an upcoming visit by a regulatory agency, such as the FDA. A gap analysis is generated indicating areas of compliance and potential improvements. Click for details.
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. OTech has assisted with the implementation of these quality systems, ranging from documenting existing processes and procedures, performing audits for compliance, to implementing a system from scratch. We have templates that can be used by vendors to be customized for the system implementation. Click for details.
Price: $ 300.00 Add to Cart
Our consultants have extensive background in the PACS/RIS area. We assist institutions with special projects that might include topics such as image quality, and/or evaluation of specific PACS components. In addition, we have a referral network for users that need support with the generation of RFP's, project management, selection, and acceptance. Click for details.
Because of the involvement of our consultants with the DICOM, HL7 and IHE standards activities, we can provide customized connectivity consulting. Click for details.
We are involved with the annual connectathon activity and therefore have experience with IHE profiles, especially in the area of radiology and patient care coordination. We provide customized training and consulting in this area. Click for details.
We provided DICOM consulting for organizations to create changes and/or additions to the DICOM standard, for vendors to share their DICOM interface requirements and generate a confromance statement, and for users to evaluate a conformance statement of a device to be used and generate a gap analysis. We also assist in troubleshooting DICOM connectivity errors, especially when there is a dispute between different vendors. We can validate your image headers and/or protocol against the DICOM. Click for details.
Our HL7 experts can define a profile for a specific implementation and generate an interface specification as well as test specific implementations. We can assist with mapping your database records into the required HL7 fields. Click for details.
We assist institutions with looking at Cyber security for devices and PACS systems as well as HIPAA compliance. Click for details.
Price: $ 300.00 Add to Cart
OTech provides expert witness services to assist in litigation by reviewing cases, provide an expert opinion or testify in court to settle disputes in the healthcare imaging and IT field. Click for details.
Price: $ 350.00 Add to Cart
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
Click here to view entire training schedule.
Click here to view the latest video regarding the DICOM sniffer.
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