Nuclivision achieves ISO 13485 certification

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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.

What is ISO 13485?

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.

Why is ISO 13485 Certification Important?

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:

• Quality Control: It ensures robust processes are in place for managing risk, addressing non-conformities, and maintaining product quality at every stage of development and production.
• Regulatory Compliance: Compliance with ISO 13485 is often required to gain access to global markets, as it satisfies both EU MDR and FDA requirements.
• Continuous Improvement: It promotes ongoing improvements in processes and product development, leading to safer and more effective solutions.

The Scope of Our Certification

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:

• Cybersecurity: Ensuring that our medical imaging software protects patient data and meets industry standards for security.
• Compliant Software Development: Following best practices in software design and coding to maintain safety and functionality throughout the software's lifecycle.
• AI Safety: Given the increasing integration of AI in medical technologies, we have implemented specific protocols to ensure that any AI components are designed, tested, and monitored for accuracy and safety.

This milestone brings us one step closer to delivering high-quality PET software solutions that improve both patient care and clinician workflows.

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References‍

• https://www.bsigroup.com/en-US/capabilities/medical-devices/iso-13485-quality-management-system/