DICOM Implementation
When adding & updating a product with (additional) DICOM interfaces, you would want to consider what implementation would suit your product best.
Making the right choices from the outset by applying expertise & experience will shorten the implementation lead-time, avoids common pitfalls and ultimately results in a reliable communication interface of good quality; adhering to the DICOM standard properly and hence maximizing interoperability with other systems.
Aspects to consider for example are
DICOM library/integration engine selection; Depending on the architecture and the technologies your product is based on a (commercial/open source) DICOM library or integration engine can be selected that suits your product's interoperability best.
Regulatory compliance; When implementing software for a medical product it is important to consider regulatory compliance; How to make sure the software meets required regulatory requirements & standards for the intended markets.
Develop according defined processes; developing software according defined processes is needed to provide evidence on how software was created and hence support establishing accordance with required regulations & standards. This entails processes defining how software is defined, created, maintained and tested, how risk analysis is applied, as well as what evidence documentation is created during software development.
Testing/Verification; A good test strategy, quality test cases & scripts and proper test data ensure that software quality is upheld properly and at the same time required test evidence is created. Automation of connectivity tests is beneficial, especially when integrated into a continuous integration environment.
Technical file items; During the process of creating medical grade software a technical file needs to be built up gradually containing plans, product documents such as manuals and a conformance statement as well as the evidence documents related to definition, implementation, risk analysis and test activities performed. Technical file items are used for submission purposes for example in order to get a CE mark for the European market, or FDA approval (510K/PMA) for the American market. The technical file also provides the evidence needed in case of an external audit by a regulatory body.
Involving ICT group brings the required capabilities to table. ICT group advises and assists manufacturers and institutions involved in the development of medical devices.
Providing you with advice on: what DICOM library/integration engine would suit best taking also into account possible licensing costs usage of a commercial DICOM library may incur. What is needed to meet regulatory requirements and create the required technical file items. What approach to take related to the development and testing of medical grade software and its DICOM communication interfaces specifically.
Proving you assistance and capacity in development by offering professional development services taking into account regulatory compliance requirements, developing software according ISO13485, testing with extensive representative test & test data sets, and delivering the design outputs needed for the technical file supporting the required documentation needed for submission for the American and/or European market.
ICT group is a partner in medical software development with special focus on standardization (DICOM, HL7, IHE), bringing both technical and domain knowledge to bare; familiar with most software development platforms (Java, C++ .NET,..), continuous integration, test automation, as well as expertise related to various healthcare domains (NM, radiology, radiation oncology, IT infrastructure,..) as well as the usage of integration engines and DICOM libraries.
Contact us at info.healthcare@ict.nl for more information. Feel free to ask for project reference sheets.
