Toronto, Canada-based CSA Group is opening a new laboratory in Irvine with the intent of winning more business from the area’s medical device and diagnostic products makers.
CSA is a nonprofit safety standards development, testing and certification company that works with a range of industries, including “electro-medical” and healthcare.
“We certify usually medical monitoring equipment. We don’t look at anything that goes into the body— stents, pacemakers, that sort of stuff,” said Fabio Furlan, operations manager of CSA’s new facility, which is on Bunsen Street in the Irvine Spectrum near Research and Irvine Center drives.
CSA already had a presence in Orange County near Barranca Parkway but moved from the 15,000-square-foot facility to the 38,000-sqaure-foot lab upon its completion.
Testing and certification of invasive devices is handled by the Food and Drug Administration, according to Furlan.
“There’s a fairly substantial medical community in Orange County all the way down to even San Diego County. We are trying to service our local customers, our local manufacturers,” Furlan said during a visit to CSA’s new facility this month.
The lab, which has space for future expansion, features testing areas where engineers break down a variety of products and test them for safety.
In one testing area, an engineer looked at an Alaris infusion device made by client CareFusion, a device maker with 240 workers in Yorba Linda that became a unit of Franklin Lakes, N.J.-based Becton, Dickinson & Co. last year.
Device Makers
Several other device makers that are based here or have local operations show up on CSA’s certification list, including Brea-based Beckman Coulter Inc., which makes diagnostic testing equipment; San Clemente-based needleless intravenous connector maker ICU Medical Inc.; and Irvine-based Biolase Inc., which makes dental lasers.
CSA has a number of competitors, including the for-profit Northbrook, Ill.-based Underwriters Laboratories Inc.
Its Irvine location now has just under 50 workers out of 1,800 companywide, but Furlan said it will be hiring an unspecified number of people, particularly electrical and biomedical engineers.
The independent company had revenue of $315 million Canadian dollars, or about $242 million, in the 12-month period ended March 31, up 8% over the year ended March 31, 2014. Net income was $11.8 million. It also has locations in cities such as Cleveland and Dallas that provide testing of equipment used in locally dominant industries, such as oil refining and consumer appliances that use natural gas as fuel.
Furlan said CSA gets clients from a combination of word of mouth and its sales force.
“We are in a competitive marketplace. We do have competitors, so we want to try and get the manufacturers to come to us,” he said, adding that CSA also conducts technical seminars as a way to attract business.
Once a device maker and CSA decide to work together, Furlan said CSA gathers information about the product, including its function and where it’s going to be used.
“We’d ask them if it’s just for North America, United States, Canada, Europe … because that also dictates what standards are used,” Furlan said of the process.
CSA then gives the client a quote and collects a number of sample products for the operation.
“Because we’re doing testing, we’d want at least more than one sample,” he said.
CSA tests the device, and “once that’s all done, we would provide the manufacturers with what we call the findings,” Furlan said.
The company issues its CSA certification if it finds no problems or if the maker corrects problems. CSA marks appear on the devices after they’re manufactured.
It also performs factory surveillance for clients—unannounced visits to their manufacturing facilities with the intent of ensuring that a product is still made to standards.
