Metrigraphics LLC Participates in Collaborative ISO 13485 Effort

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Micro flexible circuit maker foresees greater emphasis on achieving the international quality standard for medical devices.


The ISO 13485 collaboration group in which flex circuit maker Metrigraphics LLC participates has received a Workforce Training Fund Grant through the Commonwealth of Massachusetts, Executive Office of Labor and Workforce Development.

The award funds the total cost of training for the MassMEDIC/Mass MEP ISO 13485 Collaborative, which includes seven other companies in addition to Metrigraphics. ISO 13485 is the international quality standard for medical device manufacturing.

Over the next several months, the companies will work together in collaborative sessions as well as independently on-site, to prepare for certification.

Metrigraphics’ participation was a natural outgrowth of the flexible circuit maker’s commitment to quality, President and CEO Randolph J. Sablich said.

“We first went after ISO 9001-2008, even though we had a customer-approved QMS because we knew that the increased discipline would help us be more effective, and would better ensure our delivering quality products to our end customers,” Sablich said.

“As we moved more into the Medical Device OEM space, providing tier II components to a variety of customers, we knew that it was only a matter of time before the FDA pushed the 13485 requirement down to the supplier base,” he said. “We wanted to be ahead of that curve.”

From past experience with Mass MEP, the flex circuit manufacturer knew the collaborative would be a successful endeavor.

“Metrigraphics has worked with Mass MEP in the past, for Lean and Value Stream Mapping training, and while in pursuit of our ISO 9001 certification,” Sablich said. “We knew that they would be a huge help and that we could count on them to find the right people to support the effort.”

The move to acquire ISO 13485 registration is timely, he said.

“As it turns out,” Sablich said, “We already have one customer that is going for their FDA approval for US sales and our component is the single part that enables the operation of the device.

“We and our customers know that having 13485 will be a big plus and will help us expand our marketplace. We look forward to adding the registration to our growing list of qualifications.”

Mass MEP (Massachusetts Manufacturing Extension Partnership) is a training and consulting organization that develops a wide variety of programs, like the ISO collaborative, to assist manufacturers in the state. Mass MEDIC is an organization that works in support of Massachusetts’ Medical Device Industry.

Metrigraphics LLC is a Wilmington, MA-based flexible circuit manufacturer, specializing in custom precision micro circuits with features ranging in size from 2-10 microns and up to 6 metal layers with a variety of dielectrics. Visit their website to learn more.

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Randolph J Sablich
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