Software development
for medical devices

At Graylight Imaging, we specialize in producing bespoke software for medical device manufacturers ranging from embedded medical devices and Software as Medical Devices to patient therapy devices.

We are experts in developing custom medical software that combines innovation with full regulatory compliance in a specific market. The software follows the highest quality and safety standards, complying with FDA, MDR, and other applicable regulations.

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Software development for medical devices – how we work

Analysis of needs and consultation

At the beginning of the process, we establish a solid foundation for our solution. Our multidisciplinary team of ML/DL engineers, bioengineers, scientists, and clinicians ensures that your project goals are met. Together, we define the range of functionalities that will be key to achieving project requirements goals.

Software design and development

We design a system architecture that meets rigorous safety standards and ensures compliance with MDR, FDA, or other regulations. We create the technical documentation necessary to obtain approvals in the target markets. Choose us and ensure that Software as a Medical Device is tailored to your business needs.

Implementation and integrations

Our approach to implementation is individual, and it depends on many factors, such as what kind of medical algorithms or software was developed, or what clients need. Therefore, when necessary, our team will take care of the smooth installation and configuration of the created software.

Support and cooperation

At Graylight Imaging we’re your business partner. That’s why we offer more than just software. Thanks to our experience, we can effectively support you in planning the next steps of your software development in medical device, using the latest technologies and trends.

Software development for medical devices – advanced technologies

With our hands-on expertise in artificial intelligence, we create custom medical algorithms across a broad spectrum of medical image analysis. Both static images (MRI, CT, PET) and dynamic video sequences can be processed by our algorithms, providing the expected results.

Take your medical innovation to the next level. We combine our expertise in medical device software development with our knowledge of innovative technologies to help healthcare companies extend the capabilities of their medical devices. We bring experience from product development projects across a range of medical specialties and procedures.

Experienced team in building up medical device software

Detailed technical documentation. In our work, we generate, if required, evidence in accordance with IEC 62304, IEC 81001-5-1 or FDA guidelines. It’s crucial to ensure the software meets all regulatory requirements and is safe for use.

Quality Management System. We operate in accordance with our internal certified ISO 13485 quality management system. We are experienced practitioners in the development of medical software that meets the requirements of this standard.

Regulatory Compliance. Our knowledge of the ISO 14971 standard and the ability to create medical software systems while complying with the IEC 62304 standard will ensure the relevant certification if needed.

Certified medical software. Our experience in the development of certified medical devices that have successfully been implemented in clinical workflow and are used in daily basis medical practice.

Experienced team in building up medical device software

Detailed technical documentation. In our work, we generate, if required, evidence in accordance with IEC 62304, IEC 81001-5-1 or FDA guidelines. It’s crucial to ensure the software meets all regulatory requirements and is safe for use.

Quality Management System. We operate in accordance with our internal certified ISO 13485 quality management system. We are experienced practitioners in the development of medical software that meets the requirements of this standard.

Regulatory Compliance. Our knowledge of the ISO 14971 standard and the ability to create medical software systems while complying with the IEC 62304 standard will ensure the relevant certification if needed.

Certified medical software. Our experience in the development of certified medical devices that have successfully been implemented in clinical workflow and are used in daily basis medical practice.