---
title: Smalley’s ISO 13485:2016 Certified Wave Springs and Retaining Rings for Medical Devices | TFC Ltd
description: Smalley is now now ISO 13485:2016 certified. Learn more about the the preferred supplier to the medical industry.
image: https://blog.afceur.com/hubfs/Imported_Blog_Media/ISO-13485_2016-Certified-Main-Image-min.png
---
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# Smalley’s ISO 13485:2016 Certified Wave Springs and Retaining Rings for Medical Devices
Brian Vince
### Brian Vince
With 27+ years at TFC, Brian is detail-oriented, analytical, and a natural problem solver with a passion for continuous improvement and learning. His extensive experience includes qualifications in Mathematics, Physics, Engineering, Health and Safety, Auditing, Personal Training, and AI system design. Brian led TFC to achieve AS9120/AS9100 certification in 2005 and redesigned the TFC 8D process in 2023, showcasing his commitment to process improvement.
April 20, 2018
## ~Precision-engineered components supporting compact designs in surgical instruments, implants, and imaging equipment~
**As the preferred supplier to the medical industry, Smalley™s Spirolox Retaining Rings and Wave Springs are found in medical devices from surgical instruments to implantables, imaging equipment to dental tools and more.**
Smalley is now ISO 13485:2016 certified, after a rigorous, nearly year-long application process and aggressive quality audit with a third-party registrar (DQS). This international Quality Systems Standard, written specifically for medical device manufacturers, has its foundation based on ISO 9001.
For almost 40 years AFC has partnered with US-based Smalley Steel Ring Company to become the leading European supplier and technical support centre for Smalley’s Wave Springs, Spirolox Retaining Rings and Snap Rings.
The flagship Crest-to-Crest® multi-turn compression springs have always been of interest to designers because of their axial & radial space saving features. As engineers around the world design smaller and smaller assemblies, the question becomes, where can I find the compact components to support my designs?
Over the past decade, in particular, Smalley’s production team have significantly enhanced their ability to produce smaller and smaller springs to match the requirements of the medical and electronic industries. This development has culminated in the recent expansion of the popular YC & YCM series down to 0.188 inches and 5 mm in diameter with special designs being available down to 0.157 inches or 4mm in diameter.
Smalley’s unique edge-winding process enables parts to be cost-effectively manufactured from many materials, including surgical 316 Stainless Steel and implantable Titanium.
Wave Springs are produced to reliably satisfy precise operating conditions which make them ideal for accurate load, and the tight radial and axial spaces found in many medical applications. These latest manufacture developments from Smalley have created further possibilities for designers within the medical industry where typically small cavity sizes limit the available spring force properties.
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