Opto Circuits India Ltd has announced that the Company has been certified to ISO 13485:2003 from Underwriters Laboratories Inc. ISO 13485:2003 is an International Standard to provide a "harmonized" model for quality management system requirements that satisfy International Medical Device Regulations.
Medical Device Manufacturers need to ensure that all medical devices are safe, fit for their intended purpose and that their design and manufacturing quality management systems meet Regulatory requirements. This standard is recognized worldwide as an international standard. It also makes it easier to meet QSR requirements of US FDA.