ISO 13485 Certified | ISO9001 Certified Request more information or an in-office demo (267) 483-8081

Category Archives: Manufacturing

Curvebeam Achieves ISO 13485:2016 & MDSAP Certification

QualityCurvebeam announced the company’s ISO 13485 certification has been updated to the latest revision of the standard. The company’s quality system is now certified to the ISO 13485:2016 standard, which represents the most recent revision of the widely recognized manufacturing quality standard issued by the international Organization for Standardization (ISO).

In addition to 13485:2016 requirements, this certification covers the requirements of the Therapeutic Goods Administration (TGA) of Australia; Brazil’s Agencia de Vigilancia Sanitaria (ANVISA); Health Canada; the U.S. Food and Drug Administration (FDA) under the Medical Device Single Audit Program (MDSAP).

“These latest accomplishments are the result of a significant effort by our entire quality, technical and operations teams,” said Ryan Conlon, Director of Quality and Regulatory Affairs for Curvebeam. “CurveBeam’s quality system lays a strong operational foundation for continuous innovation in orthopedic imaging.”

The ISO 13485 standard is specifically designed to certify medical device manufacturers and their key suppliers. The International Standard outlines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Made in the USA

At CurveBeam, we are proud that the pedCAT is manufactured entirely in the United States. Our factory headquarters are located in Warrington, Penn., just north of Philadelphia. The factory floor is housed in the same building as our administrative, sales, and research & development offices. We are committed to creating opportunities in our community. Most of the pedCAT’s components are sourced from local manufacturers as well.

CurveBeam’s manufacturing process is certified by ISO, a developer of voluntary industry standards. Each pedCAT goes through a rigorous testing process to ensure it produces high quality images.

An engineer surveys inventory at CurveBeam headquarters.
An engineer surveys inventory at CurveBeam headquarters.

Engineers on the factory floor follow the principles of lean manufacturing, developed by Toyota. The process is easily scalable, meaning CurveBeam can react quickly to large orders or orders that require a fast turnaround time.

We would like to extend an open invitation to all foot and ankle specialists to visit us. We’d be happy to give you a tour and show you the pedCAT “behind the scenes.”

Tweet: Check out this example of high tech medical device manufacturing on American soil: http://ctt.ec/HPlnc+