Precision Coating, an Applicator of Specialized Anodic Coatings for Medical Products, Receives ISO 13485:2016 Certification

Posted Jan 28, 2019 10:54:34 AM
By Precision Coating

Global Supply Chain Leader in Anodic Coatings for Aluminum Products used in Medical Applications Updates to the Latest ISO Standard

Woonsocket, RI —January 28, 2019—Rhode Island-based Precision Coating is pleased to announce that its quality management system for anodic coating services for medical devices has been audited and found to be fully in compliance with the International Organization for Standardization (ISO) 13485:2016 standard. Precision Coating endorses its commitment to remain an innovative world leader in the medical device coating industry, consistently meeting and exceeding customers’ quality, safety, and performance expectations. Precision Coating has been assessed and certified by the Notified Body, SGS United Kingdom Limited (accredited by UKAS under registration number 0005), for the application of anodic coatings, including MICRALOX® Ultra and Lumina. Precision Coating’s fluoropolymer coating subsidiary is also ISO-13485:2016 accredited by SGS. 

The latest revisions in the ISO 13485 standard, which is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services, is in response to changes in technology and regulatory requirements and expectations. The latest standard places more emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

Because doctors and patients rely on medical devices to perform within highly regulated, top-quality parameters, Precision Coating adheres to the validated processes that provide consistent and repeatable outcomes. Quality Manager Chynna Lopes said, “We have a proven history of ensuring that we maintain our repeatable processes to their highest quality and also manage risk for all stakeholders. Achieving this updated ISO certification communicates to our customers that we will continue to uphold the quality management standards that have helped make us a dependable supply chain partner and global leader in the medical device coating industry.” 

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About Precision Coating

Precision Coating provides high-tolerance coating and specialized metal-finishing services to the medtech industry for applications including vascular, endosurgical, and orthopedic instruments and devices. Precision Coating works with early-stage device innovators through major medical equipment manufacturers, deploying comprehensive solutions—from concept to commercialization—and offering flexible prototype work through high-volume coating application, finishing, and printing services. The company operates facilities in Massachusetts, Rhode Island, and Costa Rica, and serves customers worldwide, offering seamless supply chain support.