CHICAGO – West Chicago based printed circuit fabricator American Standard Circuits has attained their ISO 13485:16 medical certification. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
President and CEO, Anaya Vardya commented, “This certification represents a great deal of work and dedication from all our team members. They all put together a tremendous effort to reach this goal. It is my understanding that there are very few printed circuit board companies (If any in North America) that have earned ISO 13485:16 Medical Certification which makes us stand out as a preferred medical electronics circuit board provider. As we continued to grow our medical business exponentially, we felt that this certification would go a long way in establishing our leadership in this marketplace. Now that we have made the investment in time and people to accomplish this certification we look forward to meeting and working with even more medical electronics companies.”