Developing medical software asks for specific healthcare knowledge. ICT Group have that knowledge, although trends such as interoperability and connectivity, as well as our clients' business goals, are just as important to us.

From prototype to compliant medical product 

Suppliers and developers of medical devices are mainly focused on functionality, safety, and reliability. They are often a bit less familiar with integration with other information systems, while this is of crucial importance nowadays. We do have the expertise to support your software development specifically in the area of interoperability and connectivity. Data engineering, data science, and cyber security are part of our development process. We embed all aspects of integration, functional safety, usability, and information security in the design to facilitate the engineering, verification, and validation and to minimise the risk of disinvestment. We provide a technical file so you can prove that the system is safe and compliant and that the risks are minimised.  

We operate mainly on a project basis, from prototype to working product. We support start-ups and scale-ups with ideas and expansion of functionalities. Cloud solutions for asset management and remote support strengthen their market position and growth potential. We control the full product life cycle and help providers to speed up their product development. We know your processes, we know the law, we are ISO 13485 certified, and we know the consequences of MDR and FDA for the development of medical equipment. With strict project management, we help to launch and manage medical products successfully, so your investments will pay off sooner and the time to market is shorter. We will give you that flying start and perfect landing. 

Related products

What makes us stand out

We are a markedly technical IT company with a profound knowledge of healthcare and medical software development. From prototype and development to long-term management, we support our clients with expertise and proven IT solutions. 

  • Support during the entire software development life cycle 

  • Thinking along from client's business goals 

  • Trusted adviser for start-ups and scale-ups 

  • Many years of experience with CE/FDA/MDR regulations 

  • Highly qualified teams 

  • Project-based solutions 

  • Platform independent system integrator 

Our qualities for the Healtcare industry

We provide proven solutions, high-quality (certified) services, and dedicated people who know the ins and outs of software development for the healthcare industry. That makes ICT Group the ideal partner for long-term cooperation. 

ISO 13485, 14971, 27001, and 9001 certified

We have an excellent quality management system (ISO13485) and meet the standards for risk management (ISO14971), information security (ISO27001), and quality management (ISO9901) for the medical industry. 

MDR and FDA submission and approval

We meet the MDR's (Medical Device Reporting, Europe) and the FDA's (Food and Drug Administration, USA) requirements for medical devices. 

IEC 62304 and 62366

We meet the IEC 62304 standard for medical software development and the IEC 62366 standard for usability of medical equipment. 

CE certification

CE certification for medical equipment. Well-documented development process, clinical equipment validation.

Connectivity 

Integration of medical equipment in the clinical workflow. Strong partnerships with platform and technology providers such as InterSystems. 

Interoperability

We provide the tools enveloping the standards, protocols, and procedures for cooperation between medical products and systems. 

ISO 13485, 14971, 27001, and 9001 certified

We have an excellent quality management system (ISO13485) and meet the standards for risk management (ISO14971), information security (ISO27001), and quality management (ISO9901) for the medical industry. 

MDR and FDA submission and approval

We meet the MDR's (Medical Device Reporting, Europe) and the FDA's (Food and Drug Administration, USA) requirements for medical devices. 

IEC 62304 and 62366

We meet the IEC 62304 standard for medical software development and the IEC 62366 standard for usability of medical equipment. 

CE certification

CE certification for medical equipment. Well-documented development process, clinical equipment validation.

Connectivity 

Integration of medical equipment in the clinical workflow. Strong partnerships with platform and technology providers such as InterSystems. 

Interoperability

We provide the tools enveloping the standards, protocols, and procedures for cooperation between medical products and systems. 

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Jorg Wissink