BioCheetah receives ISO 13485:2016 certification for Medical Device Design and Development

BioCheetah announces today that it has received the ISO 13485:2016 certification for Medical Device and Quality Management Systems for its facility in Singapore. BioCheetah has obtained this reputable certification from TÜV SÜD, one of the world’s leading inspection organizations on safety, security, and sustainability solutions.

ISO 13485:2016 is an internationally recognized standard of quality and safety for medical device industry. The management system standard ensures that an organization meets the regulatory requirements specific to the design and development of medical devices.

“We are extremely proud of the work of our passionate employees who completed the ISO 13485:2016 certification process, which recognizes that BioCheetah meets all the requirements for design and development medical devices, said CEO, Dr Lee Kian Chung. This project is the perfect demonstration of BioCheetah’s agility, speed and a testament to our commitment to safety and quality.”

“As a biotechnology company providing solutions for the healthcare sectors, this certification is expanding the company’s potential and growth opportunities,” said Eunice Teo, Director of Business Development and Operations at BioCheetah. “We continuously find innovative ways to provide solutions to deliver healthcare.”

BioCheetah prides itself as the transformation enabler between life sciences and healthcare. Their team of global advisory brings a clear understanding of the needs, constraints, and opportunities in the biotechnology industry for urological cancers.

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