Performance Motion Devices, Inc. (PMD) announced that it has received ISO 13485:2016 certification for all of its facilities, both U.S.-based and international. The ISO 13485 Quality Management Standard embodies the requirements for a comprehensive management system for the design and manufacture of medical related devices.
With this certification PMD demonstrates to the life sciences and medical community its stringent commitment to process and and quality control, becoming one of the first companies in the automation and motion control space to achieve this milestone.
As an ISO 13485:2016 certified organization, PMD can now offer medical device and lab automation engineering solutions that are tailored to address project-specific needs and requirements from concept to commercialization, while still meeting and maintaining the highest international standards of design and manufacturing quality.
The ISO 13485 standard was developed in 1996 in an effort to provide a quality management system tailored for the medical device industry and is recognized internationally. To be certified to the ISO 13485 standard, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Organizations that obtain ISO 13485 certification give their customers the confidence in the quality of the medical devices and services that they provide.