Certifications and Quality You Can Trust
Globally Recognized Standards to Support Your Cell Therapy Innovations.
Certified for Excellence and Global Compliance
At YOCON, our certifications reflect our unwavering commitment to meeting the highest global standards for cell therapy and molecular diagnostic products. Here’s how we ensure excellence and compliance:
FDA 510(k) Registration:
- Our Mesenchymal Stem Cell Serum-Free Medium is officially certified as a Class II medical device under the FDA’s stringent 510(k) clearance process (Registration No. K232543)
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- This recognition positions YOCON as a trusted partner for cell therapy manufacturers and researchers worldwide, ensuring our products meet rigorous U.S. regulatory standards for safety and efficacy.
ISO 13485 Certification:
- YOCON operates under an internationally recognized quality management system specific to medical devices.
- This certification guarantees that our products are developed, manufactured, and distributed to meet the highest standards of consistency, quality, and reliability.
GMP Compliance:
- Our state-of-the-art facilities adhere strictly to Good Manufacturing Practices (GMP), ensuring contamination-free production and consistent product quality.
- With aseptic environments certified to B+ grade cleanliness, our production lines maintain the integrity needed for high-quality cell therapy products
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Rigorous Testing for Reliable Performance
At YOCON, quality is not just a standard—it’s a commitment. We prioritize the safety, consistency, and reliability of our products through stringent quality assurance processes designed to exceed industry expectations.
Sterility Standards
- All production occurs in B+ grade aseptic environments, both in static and dynamic states, ensuring a contamination-free process from start to finish
. - Our facility integrates cutting-edge sterile filling lines and maintains strict environmental controls for temperature, humidity, and airflow, eliminating the risks of microbial or particulate contamination.
Comprehensive Internal Audits
- We implement robust internal quality audits to continually review and enhance our processes.
- These audits ensure compliance with Good Manufacturing Practices (GMP) and international standards like ISO 13485, guaranteeing consistency and quality in every product
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Advanced Testing Infrastructure
- Our facility houses state-of-the-art equipment for sterility testing, cell viability analysis, and chemical composition validation, allowing us to deliver reliable and high-performance products.
What Certification Means for You
When you partner with YOCON, our certifications and rigorous quality standards directly benefit your cell therapy projects, ensuring success at every stage. Here’s why our commitment to compliance matters for you:
Confidence in Product Safety and Reliability
- With FDA 510(k) registration, ISO 13485 certification, and GMP compliance, our products meet the highest global safety and quality benchmarks.
- You can rely on consistent performance, reduced contamination risks, and stable cell characteristics for both research and clinical applications.
Seamless Global Regulatory Submissions
- Our certified production processes simplify regulatory approval in key markets like the U.S., China, and Japan.
- Whether preparing an IND application or scaling up for clinical trials, our products are designed to support compliance with stringent local and international regulations
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Reduced Risk in Cell Therapy Development
- Our aseptic production and biocompatibility testing eliminate unknown variables, minimizing risks in drug development and manufacturing.
- This allows you to focus on your therapeutic breakthroughs without worrying about supply chain reliability or regulatory setbacks.
