SpecCoat wins ISO 13485 across all three facilities

Specialized Coating Services has earned ISO 13485 certification company-wide, including all three facilities, expanding its ability to support regulated medical device electronics. The Fremont company also completed ISO 7 certification for a new 5,000-square-foot cleanroom, tightening its medical-device manufacturing capabilities.

Why it matters: - ISO 13485 is a key quality standard for medical device manufacturing and related electronics work. - Company-wide certification gives SpecCoat customers more flexibility to move programs between sites without changing compliance expectations. - The new cleanroom adds a controlled environment for higher-cleanliness coating and assembly work.

What happened: - Specialized Coating Services, or SpecCoat, earned ISO 13485 certification across all three of its facilities. - SpecCoat’s newest Fremont, California location also completed ISO 7 certification for a 5,000-square-foot cleanroom. - The certifications strengthen SpecCoat’s support for customers building electronics for diagnostic and other regulated medical devices.

The details: - SpecCoat says the company-wide certification lets customers place work at any of the three sites with audit-ready medical device support. - The company says customers can choose the site that best fits timeline or program needs without gaps in compliance or documentation between facilities. - SpecCoat’s compliance scope also includes Nadcap, AS9100D, ISO 9001, ITAR registration and ANSI/ESD S20.20 for electrostatic discharge control. - SpecCoat is pursuing CMMC Level 2 certification to support aerospace and defense customers. - Doug Bartels, chief executive officer of SpecCoat, said the certification reflects the discipline the company brings to every program and gives medical device customers the same quality and traceability across sites.

Between the lines: - The certification push positions SpecCoat to serve more regulated work at a time when medical device customers are under pressure to document quality, traceability and cleanroom controls. - Adding ISO 13485 company-wide also reduces friction for customers that want to shift production between California and Massachusetts without reworking compliance processes.

What's next: - SpecCoat says customers, engineering partners and prime contractors can contact the company through speccoat.com to arrange technical consultations or request quotes. - The company’s CMMC Level 2 pursuit suggests further expansion in defense-related compliance. - SpecCoat will continue operating two facilities in Fremont and one in Billerica, Massachusetts, while supporting aerospace and defense, space and medical device customers.

The bottom line: - SpecCoat now has a broader compliance platform for medical device electronics, with ISO 13485 across every facility and a newly certified ISO 7 cleanroom in Fremont.