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  • Writer's pictureKirk Abolafia

Press Release: Voxel Receives ISO 13485:2016 Certification

You can download a full PDF version of the release, as well as the certification itself, below.

Voxel Innovations Press Release ISO 13485-2016
Download PDF • 134KB

Voxel 13485
Download PDF • 344KB


We at Voxel are proud to announce that our quality management system (QMS) has received ISO 13485:2016 certification, as of 9/5/23. Earlier this year, we achieved AS9100D, which includes ISO 9001:2015. These new certifications will be the catalyst of Voxel's future growth, utilizing PECM to produce high-quality medical devices, alongside critical parts in the aerospace, energy, and defense industries.

Specifically, we intend to utilize ISO 13485:2016 certification to expand our contract manufacturing business in the medical device market, producing cardiovascular devices, surgical tools, and orthopedic devices. PECM is a scalable, efficient manufacturing process ideal for high-volume, critical medical devices, such as implantable surgical staples. Additionally, to facilitate this growth, Voxel is also anticipating an expansion into a larger Raleigh facility in Q1 2024.

Our CEO, Daniel Herrington, explained, “We’re excited for Voxel to enter a new period of growth, and this ISO 13485-2016 certification will be an important step in expanding our capabilities, markets, and production capacity to better serve our customers. One of our primary goals is to draw attention to this unique technology within the medical device manufacturing industry, as we believe there is significant overlap between the manufacturing challenges in that industry and PECM’s wide range of capabilities.”

This press release has also been shared by several other publications. Note: This list will be updated as more publications publish this content.


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