Joining Technologies Certified to ISO 13485
The welding house demonstrates a commitment to processing parts to rigorous standards for medical device quality management systems of Tier 1 suppliers.
Joining Technologies, Inc. (East Granby, CT), an innovator in industrial laser applications, announces that it has successfully obtained certification to the ISO 13485 standard for the manufacture of medical devices. The company is one of very few welding service companies who have met the rigorous ISO 13485 medical device standard, setting it apart from other welding houses.
The achievement demonstrates a strong commitment to processing parts to the same rigorous standards as its major medical device customers. Attaining the new standard strengthens the company’s 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. The auditor was quite impressed with the company, commenting that the its “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.
Joining Technologies is an innovator in precision fusion processes, including laser and electron beam welding, laser additive manufacturing, and weld system design and integration. Its engineering talent continues to develop economical solutions for joining metal components primarily in the medical device, sensors, aerospace, military, energy, and firearms industries.
The company has created a corporate culture that rewards innovation and teamwork, and continues to invest in infrastructure, making it the most highly evolved and reliable operation of its kind. www.joiningtech.com, firstname.lastname@example.org.