• serch_icon1
  • people_icon

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.

 

News

  • DVTK news update – March 2020

    We are happy to inform you about the DICOM 2020a Standard DVTk definition files. At the same time, we would like to point out the new releases of the DVTk based applications.Read more

  • DVTK news update – June 2019

    We would like to draw your attention to DVTk updates coming soon and to inform you about the official DICOM standard press release of the potential DICOM 128-Byte Preamble vulnerability. At the same time, we would like to point out an important event to you taking place in the Netherlands.Read more

  • DVTK new update – November 2018

    We would like to inform you on our a upcoming training event, about DVTk being actively used as a basis for IHE-RO validation test tools, our visit to SIIM 2018 this year and thank the dvtk contributors that supported by acquiring 2018a definition files this year. Would you like to know more?Read more

  • DVTk news update – April 2018

    Dear All, We are happy to inform you about about the DICOM 2018a Standard DVTk definition files, and well as on the release of a new version of the DICOM Editor. Worth mentioning is also our presence at SIIM 2018 this year. Curious? Take a look at this news update.Read more

  • DVTk news update – May 2017

    Happy to inform you about the DVT tools release, now available for download. Also we announcing: the winning submission of the new DVTk application icon contest. Read more

  • DVTk news update – April 2017

    We would like to inform you via this news update on the DVTK initiative. As a community we are planning to make further steps regarding the DVTk open source DICOM tool set at www.dvtk.org this year. Read more