Medical Device Marking
Black Sheep Creative offers the medical community laser marking for medical devices. Many of these devices have a unique set of requirements for high precision markings. They need markings that are permanent, accurate and legible as defined by government guidelines. Unique Device Identification (UDI) is required on all medical devices, tools, implants, and instruments to ensure product identification and traceability. Our service offers consistent high quality and prevents damage to the parts being marked. These marks are corrosion resistant and can withstand sterilization processes such as passivation, centrifuging, and autoclaving.
To start your medical device marking project today or for a quote, call 512-772-3813.
UDI Regulations and Requirements
A directive from the United States Food and Drug Administration (FDA) has introduced legislation regarding the Unique Device Identification (UDI) of medical devices and instruments.
From September 2016, all medical class III devices and instruments that require direct part marking (DPM) must also carry a UDI. Class II and Class I devices will require UDI from September 2018 and September 2020 respectively.
This system will allow greater accuracy in reporting and traceability as well as reducing medical errors by allowing health care workers to quickly identify instruments.
Why Laser Marking is an Effective and Suitable Solution
- Permenant mark capable of lasting product life span
- High contrast marking
- Sterilisation resistant
- Hygienic and smooth
- Uneffected by passivation or other surface treatment