Nuclivision achieves ISO 13485 certification
September 23, 2024
Nuclivision is now ISO 13485 certified, ensuring quality and safety in our medical imaging software development and operations.
September 23, 2024
Nuclivision is now ISO 13485 certified, ensuring quality and safety in our medical imaging software development and operations.
🎉 🎉 🎉
We are thrilled to announce that Nuclivision is now officially ISO 13485 certified. This accomplishment reflects our commitment to quality, safety, and regulatory compliance in the field of medical imaging software. Special recognition goes to Tomas Brants and Simon De Keyser, whose tireless efforts were instrumental in building and implementing our quality management system in just one year.
ISO 13485 is the internationally recognized standard for quality management systems (QMS) in the medical device industry. It ensures that organizations involved in the design, production, installation, and servicing of medical devices consistently meet regulatory requirements and deliver safe and effective products. Achieving ISO 13485 certification demonstrates a company's ability to provide medical devices and software that adhere to stringent safety and performance standards.
In the highly regulated field of medical technology, adhering to global standards is essential for ensuring patient safety and product efficacy. ISO 13485 compliance is critical for several reasons:
At Nuclivision, our ISO 13485 certification covers the entire lifecycle of our medical imaging software, including development, manufacturing, marketing, and sales. This comprehensive scope includes several critical aspects such as:
This milestone brings us one step closer to delivering high-quality PET software solutions that improve both patient care and clinician workflows.