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Each of our associates has more than 15 years experience in the medical imaging and information field. We can provide advice on an as needed basis 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.
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| 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. OTech can assist you with the preparation and filing process. Click for details.
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| 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 area's of compliance and potential improvements. Click for details.
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| FDA Agent |
All foreign US manufacturers are required by the FDA to have a domestic correspondent that functions as a representative for the manufacturer. OTech functions in that role for several non-US vendors. Click for details.
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| Registration Canada |
The approval process to sell medical devices in Canada includes registration with a Canada Health approved agency. OTech can assist in generating the required documentation. Click for details.
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| 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. Click for details.
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| Connectivity |
Because of the involvement of our consultants with the DICOM, HL7 and IHE standards activities, we can provide customized consulting in the form of a connectivity gap analysis for digital modalities and/or PACS systems. We evaluate DICOM conformance statements, interface specifications, and integration profile definitions. We also generate and/or audit DICOM conformance statements for vendors; Herman Oosterwijk being the editor of this part of the standard, is well qualified for this activity. Click for details.
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| Security |
We have consulted with several vendors on their HIPAA compliance regarding privacy and security. In addition, we have a relationship with the University of North Texas school of engineering, and access to their faculty expertise and security laboratories for specialized training, projects and security assessments. Click for details.
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| Quality System |
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.
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