Voxel Innovations receives ISO 13485:2016 certification

Voxel Innovations, an advanced manufacturing company specializing in pulsed electrochemical machining (PECM), achieved ISO 13485:2016 certification last month. Voxel previously achieved AS9100D, including ISO 9001:2015 in January 2023. These certifications allow Voxel to continue its growth, using PECM to produce high-quality medical devices, alongside critical parts in the aerospace, energy, and defense industries.

PECM is a non-thermal, non-contact material removal method capable of creating small features and superfinished surfaces on metallic parts with high repeatability. Voxel uses PECM to produce high-volume, tight-tolerance metal components for the medical device, aerospace, and energy industries, including nitinol bone fixtures and microchannel heat exchangers.

Voxel initially developed PECM as a response to engineers struggling to manufacture critical components for high-stress, high temperature-flux environments that require tough-to-machine materials, as material hardness is irrelevant to PECM. PECM can also be utilized to reduce manufacturing costs for high-volume medical devices comprised of tough metal alloys, including nitinol and cobalt-chrome.

Voxel Innovations was founded in 2015 in Raleigh, North Carolina by Daniel Herrington, the current CEO. Herrington and his company intend to use 13485:2016 certification to expand Voxel’s 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 early 2024.

Herrington explains, “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.”