Today marked an important milestone for our company on the path toward excellence in quality management.
We successfully completed the Stage 1 audit for ISO 13485, the internationally recognized standard for quality management systems in the medical device industry. The session was conducted by Ms. Setareh Hassanzadeh as the lead auditor from Iranian Govaah Kosar, with the valuable support of Mr. Khashayar Mosayebi as our consultant. The audit took place at the University of Tehran Science & Technology Park, a place that symbolizes innovation and collaboration.

? What is ISO 13485?
ISO 13485 is a globally adopted standard that provides a robust framework for designing, developing, and delivering safe and effective medical devices and related software. Achieving compliance with ISO 13485 demonstrates a company’s commitment to quality, patient safety, and regulatory requirements—values that are critical in today’s healthcare ecosystem.

? Why does it matter?
For us at Bita Negar Afzar, pursuing ISO 13485 certification means:

• Ensuring the highest levels of safety and quality in our medical technology solutions
• Increasing trust and credibility with customers, partners, and regulatory bodies
• Strengthening our ability to enter and compete in international markets
• Building a culture of continuous improvement and accountability
• Aligning our processes with the best global practices in the medical device industry

During the session, Saeed Bayat, as the founder and representative of Bita Negar Afzar, also attended and had the opportunity to introduce our innovative technology, the Smart Surgical Assistant, to the audit team. This product reflects our deep commitment to innovation in healthcare and the use of artificial intelligence in medicine. It is designed to empower surgeons, support clinical decision-making, and ultimately improve patient outcomes.

The Stage 1 audit was more than just a formal requirement—it was an opportunity for us to reflect on our journey, assess our strengths, and identify areas for growth. Successfully passing this stage motivates us to move forward with confidence toward the final certification of ISO 13485.

This is just the beginning. With teamwork, determination, and a clear vision, we are confident that we will achieve full compliance and continue to develop technologies that merge quality, innovation, and trust at the service of healthcare.

#ISO13485 #QualityManagement #MedicalDevices #AIinHealthcare #Innovation #Teamwork