Healthcare Imaging & IT consulting
Welcome to OTConsulting
Our associates at OTConsulting are domain experts on connectivity between medical devices/software, including DICOM, HL7/FHIR and IHE. Our consultants are experts on security and HIPAA implementations applicable for healthcare institutions. We give 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, and compliance and implementation of new FDA design controls. Last but not least, we can provide you with legal support as expert witnesses.
Healthcare Imaging and IT Consulting
PACS/RIS Consulting
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.
Connectivity
Because of the involvement of our consultants with the DICOM, HL7 and IHE standards activities, we can provide customized connectivity consulting.
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 consulting in this area.
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 conformance 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.
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.
Regulatory FDA Consulting
510(k) Filing
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. OTConsulting can assist you with the preparation and filing process.
FDA and Quality Audit
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.
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. OTConsulting 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.
Healthcare Imaging and IT Security as well as Privacy (HIPAA)
Expert Witness for Legal Cases
HIPAA and Security: We can assist with cyber security aspects, HIPAA certification and assisting you with
compliance documentation (MDS2 forms) and HITRUST certification.
Legal consulting
Expert Witness for Legal Cases
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.
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Click for detailsThank you for contacting us! We look forward to hearing from you and the opportunity to assist. Tell us a little bit about your company and/or institution and question and we’ll be back in touch shortly