Smalley Receives “Stamp of Approval” for Medical Component Manufacturing

Quality parts make for an exceptional medical device. For many years, Smalley has been a trusted supplier to the medical industry. Our recent certification to ISO 13485 is another indicator of our dedication to delivering the highest quality retaining rings and wave springs on the market.

After a year-long approval process and quality audit with the third-party registrar (DQS), Smalley has been has received the “Stamp of Approval” for medical component manufacturers. This international Quality Systems Standard, written specifically for medical device manufacturers has its foundation based on ISO 9001.

Certifying to ISO 13485 is often the first step in complying with strict regulatory requirements. Although it is a global standard among medical device manufacturers, it is unique for a component manufacturer like Smalley to receive it.

Smalley attained this certification to guarantee the exceptional quality craftsmanship of our retaining rings and wave springs.

From standard parts to custom solutions, Smalley has designs and supplied thousands of retaining rings and wave springs to the medical industry. Our engineering expertise, material availability and ability to meet any volume requirement from prototype to production, makes us the ideal supplier to the industry.

This is the first medical specific certification for the company. Smalley maintains a Quality Management System that encompasses other industry standards. These standards include Automotive (IATF 16949) and Aerospace (AS9100C). Smalley is also certified to ISO 9001 and ISO 14001 and maintains status as an ITAR-registered (International Traffic in Arms Regulations) facility.

Learn More About our Medical Industry Capabilities