Medical Device Coatings Blog

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SSG Completes ISO 13485:2016 Audit with Zero-Findings, 3 Years in a Row!

As an ISO 13485:2016 certified company, Surface Solutions Group strives to constantly meet or exceed our customer’s requirements in quality, service and delivery. We monitor and maintain all of these and other critical operational statistics daily.

SSG participates in routine Quality Management System audits, independently conducted by NSF ISR.  The last audit concluded on July 11, 2023. The audit included a survey of SSG’s quality controls, coating and handling processes, production, employee relations, safety, and purchasing systems. The 3rd-party auditing organization concluded there were zero findings from the audited areas. In fact, SSG has passed with ZERO major or minor findings for the past three years!

Why ISO 13485:2016 Certification Matters

The ISO 13485:2016 certification is one coveted by medical device organizations around the world and is currently the highest caliber internationally accepted guideline to which a company can adhere, to validate compliance to critical rules and regulations enforced in the medical device industry.

Quality and consistency are critical when it comes to medical device coatings and performance. Our ISO 13485:2016 certification, zero findings and ZERO FDA recalls are proof of that. Throughout our entire organization, across every department, we all have the same goal in mind: To deliver the best possible coated products, with quality, precision and repeatability.

Our 13 proven medical coatings change the properties of medical wire and other devices with reliable biocompatibility and improvements to product and patient safety. That is a responsibility that we don’t take lightly. Because we know that… Every Medical Device We Coat Touches Lives®.

Surface Solutions Group is an industry leader in the application of coating technologies exclusive to the medical device industry. Our coating technology and expertise, extensive automation, and state-of-the-art facility provide customers with a consistently applied coating on every product. This uniform and repeatable coating process produces medical devices and products that customers can be proud to put their name on.

Contact us to learn more about our coating capabilities and quality processes.