In the Spring of 2020, COVID-19 gripped New York City, prompting city officials and manufacturers alike to think outside the box to address a critical need for increased testing supplies. Print Parts, a NY-based provider of 3D printing performance parts and production-grade products, stepped up to the call and produced its first-ever medical grade, FDA- and ISO-compliant product: the nasal swab.
While Print Parts has been offering advanced manufacturing solutions for half a decade, they’d never been involved in the production of a medical-grade, FDA-regulated product. They had a viable design, a raw product and Emergency Use Authorization from the FDA. However, they lacked a process that could turn the raw 3D-printed nasal swab into a medical-grade product.
They needed a quality management system to ensure the swab was produced in compliance with the Federal Food, Drug and Cosmetic Act, 21, and a process to guide the manufacturing operations. Additionally, because they had contracted with outside vendors for sterilization, packaging and distribution, they needed a way to certify the suppliers while ensuring traceability across each vendor. Without these foundational pieces in place, Print Parts could not ensure FDA compliance, nor could they present the solution for consideration by the City of New York.
Sterling PLM began by first understanding the client’s goals, existing processes and the gaps needed to be plugged to satisfy a medical production process. With that, the team created a logical process, documentation protocols and a quality management system for the entire product development lifecycle. This included standard operating procedures that would satisfy an FDA audit, a compliance-based method for inspection, an FDA-compliant vendor certification process and traceability protocols, from the point of acceptance through sterilization and shipping.
With FDA-compliant processes and protocols successfully in place, the City of New York awarded the contract to Print Parts. A few weeks into production, the city notified Print Parts that they would soon be audited for ISO 13485, a strict European regulatory requirement. Though the swabs were initially intended for U.S. use only and manufactured in compliance with the FDA’s Federal Food, Drug and Cosmetic Act, the ISO audit passed with “no observation,” indicating ample evidence to support compliance. Print Parts’ medical-grade swabs are now in use in hospitals throughout the city.
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