Press release

PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices

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PrinterPrezz, Inc., a trailblazer in combining metal 3D printing,
nanotechnologies and surgical expertise to design and manufacture next
generation medical devices, today announced the company has achieved ISO
13485:2016 certification for Quality Management Systems for medical
devices.

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PrinterPrezz brings clinicians, engineers, materials scientists and business people together to 3D p ...

PrinterPrezz brings clinicians, engineers, materials scientists and business people together to 3D print advanced medical devices and implants. (Photo: Business Wire)

ISO 13485:2016 certification is a requirement for regulatory purposes
and is an international standard that outlines the requirements for a
quality management system specific to the medical devices industry. To
be certified, organizations must demonstrate an ability to provide
medical devices and related services that consistently meet customer and
regulatory requirements. PrinterPrezz has met these standards for
fabrication and 3D printing of titanium, non-titanium metals and
advanced resin and plastic non-active implantable and non-implantable
medical devices, associated components and surgical tools for the
medical device industry.

Shri Shetty, CEO of PrinterPrezz, said, “Designing and implementing a
quality management system and achieving ISO 13485:2016 certification are
important milestones for our company that reflect our emphasis on safety
and providing high-quality devices. I am proud of the collaborative
efforts of our team which underscore our commitment to supporting our
customers, as together we revolutionize the way advanced medical devices
are developed and brought to market.”

About PrinterPrezz

PrinterPrezz’s mission is to bring more ideas for innovative medical
devices to market faster, connecting medicine and manufacturing to
become the first Medifacturing™ company in the world. By developing
advanced medical devices using processes that combine expertise in 3D
printing, orthopaedics, semiconductor and nanotechnologies,
PrinterPrezz’s ultimate goal is to provide medical solutions that enable
people to enjoy active lives longer. PrinterPrezz’s ecosystem aims to
solve challenges for various parts of the medical innovation value chain
by providing prototyping, development, and manufacturing services to
create life-enhancing medical devices. PrinterPrezz provides customers
with access to a variety of 3D printing machines, 3D manipulation
software, and 3D scanners as well as advanced manufacturing processes,
and surgeon education programs. Medical solutions created by
PrinterPrezz are designed to enable more people to live happier and more
gratifying lives. For additional information about the company, please
visit www.printerprezz.com.