Joining Technologies, an innovator in industrial laser applications, has announced that it has successfully obtained certification to the ISO 13485 standard for the manufacture of medical devices.
Joining Technologies is one of very few welding service companies to have met the rigorous ISO 13485 medical device standard, setting it apart from other welding houses. The achievement demonstrates Joining Technologies’ commitment to processing parts to the same rigorous standards as its major medical device customers.
Attaining the new standard strengthens Joining Technologies’ relationships with its current customers, and is expected to help the company grow its medical customer base, and further enhance its capabilities with Tier 1 suppliers.
Joining Technologies was audited by America Register Systems (ASR) in December and received notification that it had successfully met all requirements as of January 15, 2013. The auditor was quite impressed with Joining Technologies, commenting that the company’s ‘customer focus is evident throughout the organization’.
The formal audit included a review of the promotion and awareness of regulatory requirements as a management responsibility, controls in the work environment to ensure product safety, risk management and design control activities during product development, as well as specific requirements for inspection, traceability, process documentation and validation.