Advancing Towards ISO 13485 Certification

 

ISO 13485 is an internationally recognized standard that establishes requirements for a comprehensive quality management system tailored to the design and manufacture of medical devices. Attaining this certification is a clear demonstration of Circad Design’s commitment to upholding the highest levels of product safety, reliability, and regulatory compliance in the medical device industry. 

 

"Obtaining the ISO 13485 certification will demonstrate our ongoing efforts to uphold the highest standards for our products, ultimately benefiting our medical device customers" stated Gavin Howlett, CEO of Circad Design. 

 

Having achieved certification to ISO 9001 in 2023, many quality management principles are already enshrined in Circad Design’s core systems and processes. However, whilst both ISO 9001 and ISO 13485 share a common foundation in quality management principles, ISO 13485 has additional requirements specific to the medical device industry. These focus heavily on regulatory compliance, risk management, and product safety. 

The path to ISO 13485 certification involves an exhaustive review of Circad Design’s quality management systems to ensure that all stages of product development and manufacturing adhere to the stringent requirements set out by ISO 13485. Circad's dedicated team has been meticulously working to align its regulatory compliance, risk management and product safety processes with these standards, reflecting a steadfast commitment to excellence. 

At Circad Design, customer satisfaction and innovation have always been at the forefront of our priorities. Achieving ISO 13485 certification will reinforce our reputation as a reliable partner in the medical device sector. This certification assures our clients that we consistently meet the highest quality standards, safeguarding the safety and effectiveness of the products they rely on. 

 

By achieving ISO 13485 certification, Circad Design will continue to develop its role as a leader in quality and innovation within the medical device industry. We remain committed to advancing our capabilities and delivering excellence in every product we bring to market.