Since the Food and Drug Administration (FDA) issued new rules on labeling medical devices and required to label all devices with a Unique Device Identifier (UDI), most medical device products and parts must be labeled.
In the case of implants such as bone plates or femur or invasive surgical instruments and devices such as catheters or minimally invasive instruments, medical device manufacturers must label 100 percent of their products.
The reasons manufacturers mark their medical devices vary, while the range of tools and technology that can be used to apply these valuable markings is limited. Laser marking is one of the marking technologies of choice that offers many benefits to manufacturers worldwide. If you want the best medical device laser marking, you may navigate www.protolase.com/marking.
Image Source Google
Flawless marking, traceability and UDI marking are important product requirements for medical device manufacturers. Your product must be marked with a permanent and fully traceable mark for a variety of reasons:
- Traceability: Medical devices must be labeled to identify and track them throughout their life cycle to improve patient safety, simplify product recalls, and streamline market surveillance.
- product responsibility
- Product safety (brand protection and product piracy protection)
- Product identification: This includes identification of the manufacturer, the manufacturer and the device itself
- Compliance with regulatory bodies such as the UDI Directive
Ensuring process quality and reliability
Manufacturers have strict requirements for marking content and must ensure that only the right markings are placed in the right positions in the right sections. Their standards apply to what to mark (2D code, logotypes, or alphanumeric content) and where to place the mark. This includes ensuring that the correct part is used for marking and that the part is properly marked where it is intended to be marked (marking).