Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs


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.


verification and validation testing

July 7, 2021

Do you know the difference between verification and validation?

Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? Verification...
Read More >
View More Blogs

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos
active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis