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December 2, 2021

How laser marking ensures the safety of medical device applications

By Miranda Mclaren

The identification of medical products is essential to ensure application traceability and quality assurance. Since the Food and Drug Administration adopted a new rule for the identification of medical products to make the marking of all devices with a unique device identifier mandatory, original equipment manufacturers (OEMs) require high quality markings on all their medical devices.

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Navigating long lead times for medical device components

The pandemic has shown how susceptible the medical device supply chain is to disruption. To learn more about the risks and opportunities, enter your details to download your free whitepaper here.
by Custom Wire Technologies
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Laser marking is the preferred method of marking technologies for manufacturers worldwide, with markings appearing on a variety of medical devices such as orthopaedic implants and other medical instruments. Laser product identification marks are corrosion resistant and can withstand processes such as passivation and centrifugation, along with sterilization via autoclaving, UV and gamma irradiation, making them the most effective option for medical device marking.

Laser marking is a non-contact form of engraving and offers consistent high quality laser marks at high processing speeds whilst eliminating any potential damage to the parts being marked.

Unique identifiers

From tubes, shafts, and clips to syringes and catheters, the medical device industry is home to a vast array of curved and complex surfaces which need to be marked. Their markings must be consistent and precise to conform to stringent regulations. Laser marking can add unique identifiers such as part numbers, lot numbers, descriptions, and company logos to a variety of applications.

Manufacturers in the medical market are moderated by very strict regulations, including the latest UDI (Unique Device Identification) and MDR (Medical Device Regulation) standards which are constantly evolving due to changing patient needs. Correct part identification is essential to ensure absolute product traceability. Laser marking is the ideal method to create these marks, offering an increase in production efficiency and decrease in costly product scrap.

Experienced laser marking

Custom Wire Technologies (CWT), a leading supplier of microfine wire for medical device components and specialists in custom orthopaedic instruments, understands the importance of high-quality product markings for OEMs.

CWT’s laser marking capabilities can add unique identifiers to a range of products of varied materials and sizes used within the medical industry, including contrasting marks on dark oxide nitinol. Additionally, CWT can add depth bands to guide wires, k-wires, and pins to present visual feedback to an end-user on how far a component may be inserted.

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Due to an increase in industry demand, CWT outgrew its suppliers’ capability to deliver quality product markings in a timely manner, and in 2018 the company made the decision to add laser marking and laser ablation for PTFE removal to their expanding arsenal of services.

Medical device laser markings are key product requirements for medical device producers that ensure traceability, product safety, and regulatory compliance through product identification.

With the demand for markings increasing, and no suggestion of it slowing down, 2020 saw CWT purchase a second system capable of significantly faster cycle times. With this new acquisition, Custom Wire Technologies is securing its position as a lead service provider, building on 50 years of industry experience, and continuing to provide high quality products through implementing the latest technologies.

To find out more, download the whitepaper below.

Free Whitepaper
img

Navigating long lead times for medical device components

The pandemic has shown how susceptible the medical device supply chain is to disruption. To learn more about the risks and opportunities, enter your details to download your free whitepaper here.
by Custom Wire Technologies
Enter your details here to receive your free Whitepaper.

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