ISO 13485 certification: Graylight Imaging new market capabilities
In November 2023, Graylight Imaging obtained ISO 13485 certification, an important milestone in the company’s development and in medical software development. At the time, the certification confirmed our ability to design, develop, integrate, and maintain medical software tailored to our clients’ needs. Today, we are taking another important step. We have expanded the scope of our ISO 13485 certification.
ISO 13485 certification for the Quality Management System – why this change?
This change confirms the advancement of our quality processes and reflects the evolution of Graylight Imaging as a company and a developer of software for the medical industry.
The previous scope covered the design and development, integration, and maintenance of medical software for image data analysis and numerical simulations commissioned by medical device manufacturers.
The scope has now expanded to include the design and development, marketing, integration, and maintenance of medical software for image data analysis and numerical simulations.
From technology partner to medical device manufacturer
A natural step in Graylight Imaging’s development was to create its own product. Although this change in certification might seem minor at first glance, in practice its significance is immense.
Until now, we have operated within the medical device ecosystem primarily as a technology partner and development contractor for manufacturers. Our certified Quality Management System has supported the development and maintenance of software that our clients have brought to market.
Following the expansion of the scope of certification, the Quality Management System in place at Graylight Imaging now also covers activities related to the marketing of our own medical software.
Graylight Imaging has been consistently growing as an organisation. A natural step in this growth was the creation of our own product – the BRIGHTER radiology platform, designed for the analysis of cardiac images. The platform has obtained MDR certification, which opens the door to its commercialisation. The expansion of our ISO 13485 certification scope allows us to bring our product to market in accordance with the highest industry standards. We want our customers to be confident that we operate based on rigorous quality requirements in this area as well, says Marek Pitura, Head of Project Management.
Controlled Quality Management System
Being a medical device manufacturer entails responsibility for the entire product lifecycle – from concept and design, through development and processes related to bringing the product to market, all the way to post-sales support.
The expansion of our ISO 13485 certification scope confirms that we are prepared to carry out this cycle of tasks within a structured and controlled quality management system.
What does this mean for our customers and partners?
1. Graylight Imaging as a medical device manufacturer
We can carry out projects in which we act not only as a technology partner and development contractor, but also as a medical device manufacturer, taking responsibility for the entire product lifecycle.
2. A shorter path from innovation to commercialization
This expansion of our capabilities allows us to transition more efficiently from the development stage to the market launch of innovative solutions in the fields of medical image analysis and numerical simulation. This is particularly important for projects where technological innovation must go hand in hand with quality and regulatory compliance requirements.
3. A single quality system for the entire product lifecycle
Design, development, integration, marketing, and service are all carried out within the framework of the same Quality Management System. For our partners, this means the opportunity to collaborate with a company whose processes are organised in accordance with the quality and regulatory requirements specific to medical devices.
The next stage in Graylight Imaging’s development
Obtaining ISO 13485 certification in 2023 was an important step in building a solid foundation for the development of medical software. Expanding the scope of certification is the next stage on this journey. It confirms the maturity of our quality processes and the development of our own medical software portfolio, particularly solutions based on innovative concepts. For Graylight Imaging, ISO 13485 is more than just a certification. It is a framework that supports the way we design, develop, manage, and commercialise medical software.