Microtech Welding Corp, based out of Fort Wayne, Indiana who serves medical device manufacturers across the United States has obtained approval for ISO 13485.
ISO 13485 is considered to be the inline standard and requirement for all medical device manufacturers and obtaining ISO 13485 status was over a year long process for Microtech. Microtech had to demonstrate the following components to prove their quality system is effectively implemented and maintained:
- Awareness and promotion of medical market specific regulatory requirements as a management responsibility
- Work environment controls that ensure product safety
- Focus on risk management and design control during product development
- Requirements for inspection and traceability for medical implant devices
- Requirements for documentation and validation of processes for sterile medical devices
- Requirements for verification of the effectiveness of corrective and preventative actions
- Requirements for cleanliness of products
By obtaining ISO 13485, Microtech aims to continue to be the world leader in medical device laser beam welding (LBW) and gas tungsten arc welding (GTAW), serving customers in Indiana, Minnesota, Tennessee, Florida, Massachusetts, Wisconsin, Pennsylvania, Texas, California, and Alabama.