We are proud to announce that we have received the distinguished ISO 13485:2016 certification for our quality management system from BSI NL.
ISO 13485:2016 is considered to be the gold standard for medical device companies to ensure the quality, safety and efficacy of products.
“The certification to ISO 13485:2016 represents an important milestone for our company and allows us to offer our customers a streamlined path from concept to clinical trials and beyond to regular series manufacturing", Dr. Simon Champ, CEO of BellaSeno, said. “BellaSeno has developed a flexible and responsive QMS capable of handling the most critical aspects of medical device product development and manufacturing."
BellaSeno's customers can use the company’s systems and experience to help achieve a streamlined path to clinical trials and beyond to regular series manufacturing.
“BellaSeno has always been committed to producing Additive Manufactured medical devices that exceed our customers’ expectations. In order for our quality management system to receive the ISO 13485:2016 certification, we had to undergo a rigorous 5-day audit process conducted by BSI NL,” explains BellaSeno's CTO, Dr. Mohit Chhaya. “Our employees’ expertise and commitment to quality were evident throughout this entire process and I am extremely proud of their accomplishments.”
Visit our Quality page to learn more about the ISO 13485:2016 certification of BellaSeno's quality management system.