Oraldent Ltd proudly announces a landmark achievement in our quest for unparalleled quality and safety in the oral health and wellness industry. We’ve secured the coveted ISO 13485 certification from BSI, reflecting our unwavering dedication to the highest standards of medical device manufacturing.
What is ISO 13485?
ISO 13485 is the gold standard for quality management systems in the medical devices field, derived from the principles of ISO 9001 and tailored to meet stringent sector-specific regulations. This certification is globally acknowledged, underscoring a company’s commitment to regulatory compliance, risk management, and customer satisfaction within the medical device industry. It’s more than an accolade—it’s a symbol of trust and a promise of quality to customers and partners worldwide.
Why ISO 13485 Matters to Us – And You?
For Oraldent, achieving ISO 13485 certification isn’t just about recognition; it’s about embodying a culture of continuous improvement. It assures our stakeholders of our capability to consistently deliver products that meet regulatory requirements and client expectations. Our comprehensive QMS encompasses everything from risk management and regulatory compliance to device traceability and documentation control—essential components for excellence in medical device production.
Our Commitment to Quality and Innovation
Our journey to ISO 13485 accreditation illustrates our proactive approach to quality service delivery and our investment in research and development. It’s a testament to our collaborative efforts in distributing and marketing a portfolio of products that not only innovate but also ensure the highest degree of reliability and safety.
Gratitude and Future Outlook
The entire team at Oraldent has been integral to this achievement, showcasing resilience and dedication throughout the certification process. We extend our deepest gratitude for their efforts and to our customers for their unwavering trust. This milestone is not just a celebration of where we are today but also a beacon for our future aspirations in the oral health sector.
As Oraldent Ltd steps into this new phase, we reaffirm our commitment to advancing oral health and wellness through quality and innovation. Our ISO 13485 certification is more than an award; it’s a cornerstone of our promise to enhance customer well-being with every product we offer.
Join us in celebrating this proud moment and discover the difference of our ISO 13485 certified products. Trust in our dedication to excellence and let us support your oral health journey with the utmost confidence.