IRD Achieves ISO 13485:2016 Certification, Strengthening Commitment to Medical Device Manufacturing
LITCHFIELD, Minn. — August 18, 2026 — PNE, Inc. dba IRD Glass and IRD Ceramics (“IRD”), a manufacturer of precision optical glass and technical ceramic components, is proud to share that it has achieved ISO 13485:2016 certification, an internationally recognized quality management system standard for organizations serving the medical device industry.
The certification, effective July 21, 2026, was issued by EAGLE Registrations Inc. and covers IRD’s operations as a “Manufacturer of precision glass, optical and ceramic components, including those used for medical device applications.”
ISO 13485:2016 establishes rigorous requirements for quality management systems supporting the consistent design, development, production and delivery of products used within the medical device industry. Achieving certification demonstrates IRD’s commitment to robust quality systems, process control, risk management, traceability and continuous improvement.
“Achieving ISO 13485 certification is an important milestone for IRD and for the customers who trust us with their most demanding applications,” said Todd, Vice President of Business Development at IRD. “Our teams have built a culture around precision, quality and solving difficult manufacturing challenges. This certification gives medical device companies additional confidence that the same capabilities and craftsmanship they expect from IRD are supported by a quality management system designed for the requirements of their industry.”
IRD specializes in the precision manufacturing of glass, optical and ceramic components for applications where tight tolerances, challenging geometries and demanding performance requirements are critical. The company works collaboratively with customers from early-stage development and prototyping through production, helping solve manufacturing challenges involving specialized materials and complex components.
The ISO 13485:2016 certification strengthens IRD’s ability to support existing and prospective customers in the medical device market while complementing the company’s broader precision manufacturing capabilities.
“For us, this isn't simply about earning a certification,” Todd added. “It is about becoming an even stronger manufacturing partner. Medical device companies need suppliers that understand the importance of consistency, documentation, responsiveness and disciplined execution. ISO 13485 reinforces our commitment to delivering on those expectations.”
About IRD
PNE, Inc., dba IRD Glass and IRD Ceramics is a precision manufacturer specializing in custom glass, optical and ceramic components for demanding applications. Based in Litchfield, Minnesota, IRD combines specialized manufacturing expertise, advanced processes and close customer collaboration to solve challenging component and material problems.
Guided by its values of Partnership, Pride and Innovation, IRD works with customers across medical, industrial and other high-performance markets, supporting programs from development and prototyping through ongoing production.