ICT Group are system integrators and specialists in medical software development. We are ISO 13485 certified and support you in every stage of the development cycle, from prototype to working and safe medical product.

Smooth interoperability 

Medical equipment and software developers and suppliers are mainly focussed on its functional, safe, and reliable use. Integration, communication, and medical data exchange with other systems and software usually requires external expertise. ICT Group offer you this expertise. We combine our knowledge of technology, safety, and integration with a profound domain knowledge of the clinical practice. This helps us to support you through the complete go-to-market process for medical equipment with smooth interoperability for an efficient workflow, minimum risk of errors, and optimum patient data security. In addition, we carefully draw up a technical file with the requirements, risk analysis, testing, and traceability, to make sure you comply with all applicable laws and regulations. 

Complying with CE, FDA, and MDR 

With our clients, we also explore new opportunities and challenges, for instance in the area of further system integration, cloud-based solutions, even stricter security requirements, and the groundbraking possibilities of AI. We provide innovative, integrated automation solutions to start-ups and scale-ups that bring innovative equipment to the healthcare market, and suppliers of medical imaging and measuring devices, among others. We guide medical equipment manufacturers through the intense process towards CE certification, FDA submission & approval, and the relatively new Medical Devices Regulation (MDR). The Medical Software Development team offer a v

Extensive domain knowledge of the medical product market

Over 40 years of experience in software development for medical products have gained us a profound domain knowledge. Combined with our interoperability and certification expertise, this ICT Group the perfect partner for medical software development. 

Audit, training, and analysis

We perform internal and external audits to safeguard the process and medical product quality, provide a wide range of training sessions, analyse the compliance, and offer QA/RA support for design, development, verification, and validation. 

Defining requirements

We define and manage user requirements, design medical user experience (in accordance with IEC62366 standard), and analyse the impact of software solutions on privacy and security laws and regulations (AVG, ISO 27001, and HIPAA). 

Design

We design software architecture and software requirements for connected medical equipment. 

Engineering

We develop embedded software (in accordance with IEC60601 standards) and firmware, client applications, and web-based and cloud-based software solutions (Azure and VMware among others). 

Verification & validation

We provide test management (test aproach, test cases, test reports), verification automation (DICOM with DVTk, among others, test stages, and process supervision for clinical validation.  

 

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Audit, training, and analysis

We perform internal and external audits to safeguard the process and medical product quality, provide a wide range of training sessions, analyse the compliance, and offer QA/RA support for design, development, verification, and validation. 

Defining requirements

We define and manage user requirements, design medical user experience (in accordance with IEC62366 standard), and analyse the impact of software solutions on privacy and security laws and regulations (AVG, ISO 27001, and HIPAA). 

Design

We design software architecture and software requirements for connected medical equipment. 

Engineering

We develop embedded software (in accordance with IEC60601 standards) and firmware, client applications, and web-based and cloud-based software solutions (Azure and VMware among others). 

Verification & validation

We provide test management (test aproach, test cases, test reports), verification automation (DICOM with DVTk, among others, test stages, and process supervision for clinical validation.  

 

Read more

What makes us stand out

  • Your medical software always up to date 

  • ISO 13485 certified 

  • Support for start-ups and scale-ups 

  • Specialist in operability and certification 

  • Trusted advisor for developers and suppliers 

More information?

Please contact Jorg Wissink

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Jorg Wissink

Would you like working on medical software development?

Medical software development requires expertise, inventiveness, and a goal-oriented mentality. As a member of our team of specialists, you make a direct contribution to our clients' success. 

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