Achieving Excellence: Pars Tarava’s Commitment to International Standards in Medical Device Manufacturing
In the rapidly evolving field of medical technology, ensuring the highest levels of quality, safety, and efficacy is paramount. At Pars Tarava, Iran’s pioneering manufacturer of Electroporation and Electrochemotherapy devices, we are proud to lead the way in innovation while upholding rigorous international standards. As the first company in Iran to produce these advanced medical devices, we are dedicated to delivering cutting-edge solutions that meet global benchmarks, empowering healthcare professionals to provide superior patient care.
Our journey is built on a foundation of excellence, reflected in the comprehensive certifications and standards we have achieved. These accolades not only validate our manufacturing processes but also assure our clients and partners of the reliability and safety of our products. Below, we detail the key standards that underscore our commitment to quality.
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Quality Management and Medical Device Standards
- ISO 9001 (Electroporation and Electrochemotherapy): This certification highlights our robust quality management system, ensuring consistent product quality, operational efficiency, and unwavering customer satisfaction. By adhering to ISO 9001, we maintain a structured approach to meeting and exceeding client expectations across our entire product line.
- ISO 13485 (Electrochemotherapy): Specifically tailored for medical devices, this standard demonstrates our compliance with stringent regulatory requirements for design, development, production, and distribution. It ensures that our Electrochemotherapy devices are safe, effective, and aligned with international best practices in medical device quality management.
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Electrical Safety and Electromagnetic Compatibility
- IEC 60601-1 (EMC): This standard focuses on the basic safety and essential performance of medical electrical equipment, with an emphasis on electromagnetic compatibility (EMC). It guarantees that our devices operate reliably in various electromagnetic environments without interference, protecting both patients and operators.
- IEC 60601-1-2: Complementing the above, this standard addresses electromagnetic disturbances, ensuring our equipment’s immunity and emissions are controlled to prevent any risks in clinical settings.
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Software Validation
- IEC 62304: This certification validates the lifecycle processes of our medical device software, from development to maintenance. It ensures that our software is reliable, traceable, and capable of performing as intended, minimizing risks associated with software failures in critical applications.
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Biocompatibility and Sterility Standards (Kiananozist)
Our commitment extends to biocompatibility and sterility, crucial for devices that interact directly with the human body. Through our Kiananozist initiatives, we have achieved the following ISO 10993 series certifications, which evaluate biological risks:
- ISO 10993-3: Genotoxicity testing to ensure no genetic damage from device materials.
- ISO 10993-4: Hemocompatibility evaluation for interactions with blood.
- ISO 10993-5: Cytotoxicity testing to confirm non-toxicity to cells.
- ISO 10993-10: Irritation and skin sensitization assessments.
- ISO 10993-11: Systemic toxicity evaluations for overall body impact.
- ISO 10993-23: Tests for irritation specifically related to medical devices.
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Additionally, for microbiological control and sterility assurance:
- ISO 11737-1: Estimation of microbial populations on products.
- ISO 11737-2: Validation of sterilization processes.
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These standards collectively affirm that our devices are biocompatible, sterile, and safe for clinical use, reducing potential adverse reactions and enhancing patient outcomes.
At Pars Tarava, these certifications are more than just badges—they represent our relentless pursuit of innovation and safety in healthcare. By integrating these global standards into our operations, we not only comply with international regulations but also pioneer advancements in Electroporation and Electrochemotherapy technologies in Iran and beyond.
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We invite healthcare professionals, researchers, and partners to explore how our certified devices can transform your practice. For more information or to discuss collaboration opportunities, please reach out:
📞 Phone: +98 902 405 1862
📧 Email: info@persiantarava.me
Stay tuned for more updates on our blog as we continue to push the boundaries of medical technology. Together, let’s advance healthcare for a healthier future.
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