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ADDMAN Group Elevates Medical Device Manufacturing Through Enhanced ISO 13485 Certification

Ontario, NY – Jan 23, 2024 – In a significant move to bolster its position in the medical manufacturing industry, ADDMAN Group is thrilled to announce a major enhancement to its ISO 13485 certification. This expansion, featuring the integration of two state-of-the-art 3D Systems 320 machines, represents another advancement in ADDMAN’s ability to serve the medical manufacturing community. The ADDMAN team has been a beacon of innovation and excellence in this field since achieving its initial ISO 13485 certification in 2016.

The expansion of the ISO 13485:2016 certification capabilities is a testament to ADDMAN’s commitment to diversifying its manufacturing capabilities and delivering comprehensive solutions within the medical device sector. ISO 13485:2016 is the international standard for quality management systems in the medical device industry, focusing on meeting regulatory and customer requirements.

ISO 13485 offers a diverse range of benefits for customers in the medical device sector:

  • Quality Management: The certification provides a robust quality management system framework essential for the high precision and consistency demanded in metal additive manufacturing.
  • Regulatory Compliance: It signifies compliance with global regulatory standards, critical for participation in the international medical device market.
  • Risk Management: The standard underscores the importance of risk management across the product lifecycle, addressing the unique challenges of metal additive manufacturing.
  • Product Safety and Efficacy: It ensures that medical devices produced meet stringent safety and performance standards.

ADDMAN’s response to the evolving requirements of the medical industry underscores its commitment to quality across various manufacturing technologies.

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ABOUT ADDMAN

ADDMAN delivers solutions to serve customers from prototyping and development projects, all the way through product end-of-life.

ADDMAN manufacturing network is comprised of 4 different companies and over 500 employees, with a coast-to-coast production footprint. Each brand adds unique manufacturing capabilities to the portfolio. The Group is inherently additive-enabled and has significant expertise in both metal additive manufacturing and polymer 3D printing. On the traditional manufacturing side, ADDMAN has 3 facilities dedicated to precision CNC machining and a site with injection molding capabilities.

All these manufacturing modalities are backed by a team of engineers, with diverse industry expertise to guide customers and help them solve complex challenges. As a start-up business, ADDMAN’s guiding charter as they scale is “any part, any volume, every step of the way”. ADDMAN infrastructure allows us to deliver full lifecycle solutions that support every phase of our client’s product roadmaps.

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