Graylight Imaging is ISO 13485 certified


 In November 2023, we wrote about the fact that we, as Graylight Imaging, have successfully passed ISO 13485:2016 certification. This is an international standard that specifies the requirements for a quality management system (QMS) for medical devices. We wrote more about our goal of achieving this standard in this article: Software as a Medical Device – Graylight Imaging is now ISO 13485.

Today’s post is dedicated to a different issue, namely that in January 2024, we received a physical version of the TUV Nord certificate, which we want to share with you!

Achieving ISO 13485:2016 certification underscores our unwavering commitment to producing products that embody exceptional quality and dependability. Software development aligns with industry-proven best practices and standards, guaranteeing best practices and standards, such as IEC 62304 and ISO 14971, as well as taking into account risk and clinical assessment. We are also able to adapt to changing market and regulatory requirements, such as the Medical Device Regulation (MDR).

Our mission is to provide innovative SaMD solutions that help doctors and patients make better medical decisions. We believe that software can play a key role in improving the quality of healthcare.

We offer medical imaging solutions in the following areas:

  • systems for the analysis and visualization of medical images, using artificial intelligence and machine learning to improve the quality and accuracy of diagnostics;
  • medical image acquisition and processing systems, providing high resolution and data rate, as well as compatibility with various imaging modalities;
  • systems for managing and sharing medical images, enabling easy integration with IT systems in medical facilities, as well as secure access to images via the Internet

Are you looking for a company that will create medical software that complies with changing market and regulatory requirements (including the Medical Device Regulation – MDR)? Contact us.