Software for medical device
We are Graylight Imaging, an ISO 13485-accredited software development company. We will navigate you through the complexities of software for medical device development and deliver the code that meets your ideas and needs.
Our expertise, coupled with our ISO 13485 certification, ensures that your products developed with us will meet the highest standards of quality and safety, streamlining the regulatory approval process.
Partner with us to transform your medical device vision into a reality.
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Outsourced medical coding
If you require assistance with medical algorithms or medical software development, or if you want to develop software for medical devices, you do not have to bear the burden of developing a medical project alone. You can utilize outsourced medical coding services.
We are an IT company that specializes in healthcare, and we can be your trusted partner for medical software development. Our experience includes developing medical software tailored to your specific needs, certified solutions, as well as complex systems based on artificial intelligence. We have developed advanced machine learning algorithms and built systems for analyzing medical images.
We provide comprehensive support for the entire process of healthcare software development. This includes conceptual work, algorithmic work, and managing the entire software development process. We will verify and develop your idea, as well as propose our concepts to ensure that you receive the best possible service.
and more years of experience in developing medical software
weeks to assemble a team for you
ISO 13485 software development
If you need help creating certified medical software, we provide comprehensive assistance. Our services cover everything from risk assessment and technical documentation that meets regulatory standards to the development of medical applications. We will guide you through the entire software development life cycle (ISO 13485 software development and more), helping you define your project goals and responsibilities, and determining the appropriate medical device classification. Our team can produce and deliver all necessary documentation in compliance with MDR and FDA regulations.
We have extensive experience in providing medical software that meets medical standards and legal requirements. Our expertise includes:
- Experience in ISO 3485 software development that complies with standards.
- Adherence to the IEC 62304 standard and expertise in the ISO 14971 standard, enable us to develop healthcare software systems that comply with regulations and obtain necessary certifications.
- Experience in FDA and CE-compliant software development.
Let’s talk
Ready to take your medical software to the next level?
Contact Przemek now to discuss how we can support you in reaching your business objectives.
Clients and partners
Testimonials
Collaborating with Graylight Imaging was seamless despite the tight project timeline. All stages were efficiently executed according to the plan. GLI fully comprehended the project’s objective and provided valuable support with their technical and medical expertise. Their specialists successfully carried out several key tasks, including developing a predictive model for medical data analysis, conducting UX analysis, creating the application’s GUI, and preparing certification documentation. A truly remarkable partnership.
Collaborating with Graylight Imaging was seamless despite the tight project timeline. All stages were efficiently executed according to the plan. GLI fully comprehended the project’s objective and provided valuable support with their technical and medical expertise. Their specialists successfully carried out several key tasks, including developing a predictive model for medical data analysis, conducting UX analysis, creating the application’s GUI, and preparing certification documentation. A truly remarkable partnership.
Working with Graylight has been a game-changer in our software projects. Their real expertise in software development, combined with robust computer science skills, allowed them to unravel complex problems effortlessly. What stands out is their proactive approach – always suggesting improvements and pushing beyond initial requirements. Their unique blend of quality and regulatory expertise adds immense value, delivering not just code but also quality documents that are a must for medical software.
Communication is a breeze, always friendly and dependable making them the rare subcontractor you want to work with.
Medical device design software
At our company, we are committed to providing advanced medical software development solutions while also creating a direct connection between our clients and the medical community.
Our approach ensures that clients have easy access to medical experts, facilitating consultations and knowledge acquisition that is specific to their ongoing medical software development projects.
We foster these kinds of connections, which ultimately result in better outcomes for our clients and the medical community as a whole.
Contact our team
If you want to talk about medical algorithms and software development, contact Przemek and discuss your specific needs and how we can help you achieve your goals.
If you would like to talk about the business side of your project, project planning and management, or risk management contact Ewa and find out how your project will be organised.
