Sutura Receives ISO 13485:2003 Certification for SuperStitch

Sutura has announced the completion of a successful audit leading to a number of certifications for the manufacture of the company's SuperStitch closure product line.

The audit verified compliance with the quality standards required in the medical device industry, including ISO 9001:2000, ISO 13485:2003, European Directive 93/42/EEC Annex II and Health Canada's Canadian Medical Device Regulations.

Specifically, Sutura received the ISO 13485:2003, "Medical devices-Quality management systems-Requirements for regulatory purposes" certification and the ISO 13485:2003 Canadian Medical Devices Regulations for the Canadian market. The ISO 13485:2003 is a newly established and internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements.

To obtain the certification, Sutura demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical devices and related services.