Standards Improve Medical Device Manufacturing

rms Company

As one of the leading medical device contract manufacturers in the world, rms Company understands the importance of high-quality products that are reliable, effective, and safe for patients. One of the ways we ensure that our products meet these requirements is by utilizing ASTM International standards throughout the manufacturing process.

We use ASTM specifications in various stages of the process, including incoming inspection, additive manufacturing (AM) processes, conventional machining, cleaning, passivation, and inspection. By adhering to these standards, we ensure that our products meet the required quality and safety regulations.

At rms Company, nearly all the raw materials procured leverage ASTM standards to ensure the incoming material meets industry-accepted values for manufacturing quality, mechanical strength, and chemical composition.

In our additive division, we use a variety of standards to control everything, from the way we handle and reuse our AM powders to controlling calibrations, validations, and maintenance on our AM systems. The specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (extra low interstitial) with powder bed fusion (F3001), which is the material standard for PBF-L-produced Ti6Al4V material, is an important standard that ensures we are delivering quality products to our customers.

ASTM standards also save rms Company and our customers significant time and costs in working with the U.S. Food and Drug Administration (FDA) to gain clearance for new devices. Referencing specifications such as the guide for powder reuse schema in powder bed fusion processes for medical applications for additive manufacturing feedstock materials (F3456) allows rms Company to provide the FDA with the information they need to efficiently review new product submissions.

rms Company prides itself on providing a comprehensive collection of numerous processing steps that are common in medical device manufacturing. These processes include, but are not limited to, wire EDM, tumbling, abrasive blasting, deburring, milling, turning, cleaning, passivation, anodizing, laser-marking, CT Scanning, CMM inspection, assembly, and packaging. Many of these processes are also controlled by ASTM standards. For example, depending on the material, we can reference a variety of specifications, such as A380, A967, and B600, to control our cleaning and passivation processes. We also laser-mark our products in accordance with the standard practice for surface preparation and marking of metallic surgical implants (F86).

Our commitment to quality is further demonstrated by our newly accredited internal laboratory, which certifies and characterizes our products. We leverage numerous ASTM test methods, such as E8, to analyze our products for mechanical strength, as well as E1409, E1447, E2371, and E539, to determine the chemical composition of our material.

Worker safety is the number one priority at rms Company. We rely on standards to ensure we conduct our manufacturing processes in the safest way possible. For example, additive manufacturing of metals — environment, health and safety — general principles for use of metallic materials (ISO/ASTM 52931:2023) provides guidance on everything from metal additive facility requirement, operator PPE, and the necessary precautions and equipment needed to prevent and react to potential fire and explosions.

At rms Company, we have engineers who are active in the ASTM community, especially on the committees on additive manufacturing technologies (F42) and medical and surgical materials and devices (F04). Our engineers take part in the development of new standards and the revision of existing ones, ensuring that our manufacturing processes stay up to date with the latest standards and technologies. By being actively involved in the ASTM community, we can also provide feedback on the practicality and effectiveness of the standards, which can help improve them for the benefit of our customers and the entire industry. ■

Company Snapshot

Headquarters: Coon Rapids, Minnesota, USA
Description: rms, a Cretex Medical company, is a trusted contract manufacturer to the top medical device manufacturers in the world. They provide precision machining and additive manufacturing of implantable devices, components, assemblies, and custom instrumentation, as well as metal fabrication of chassis, enclosures, and sterilization cases and trays.
Number of staff: 1,300
Trading Area: Global

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