A Complete Guide to the Medical Device Labeling Process

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Medical Equipment Labels | Royal Label

A Complete Guide to the Medical Device Labeling Process

At Royal Label, our medical device label printing process is done by industry professionals who follow a stringent no-defect policy. By adhering to these guidelines, we can guarantee that the labels we manufacture are of the highest quality, meet our clients’ unique needs, and continue to make us the premier medical label company in Boston, MA.

What is the Printing Process?

Medical device label printing begins with a manufacturer receiving a quote from a printing company and developing the exact product they need. The next step is collaborating to create a print-ready file and define the labels’ requirements. After this, a digital printing process ensures they are readable and scannable. Other methods include die cutting and finalization to guarantee that all items are cut to exact specifications and fit the medical products they were made for.

We use a segregation process when we print digitally designed labels to monitor product quality. This is a process that we have down to a science to ensure the labels we produce for sterilized products are accurate and include all client specs. We use these techniques to print medical equipment labels to make sure they will stand up to the wear and tear they will face in real-life applications. This includes extreme temperatures, sterilization, and repeated washing. At Royal Label, we always want to ensure that the product’s safety, effectiveness, and performance is not diminished due to inadequate product labels.

Your Medical Device Label Questions — Answered

Medical device labeling systems must have the most accurate information, such as instructions that a single-use medical device should not be re-sterilized, cleaned, or reused. At Royal Label, we often receive questions about our medical device label printers and how we produce clinical trial labels, custom medical labels, and printed medical labels. We have listed the most common questions and our expert answers:

What type of device is the label applied to?

We can print labels for and on virtually any device, in addition to providing supplementary printed information such as Information for Use (IFUs). Royal Label prints for each of the three classes the Food and Drug Administration (FDA) categorizes medical devices into: Class I, II, and III. This is essential because the FDA requires manufacturers to adhere strictly to these classification requirements. These guidelines prevent careless mistakes by detailing proper application methods and can prevent severe injuries and fatalities that may result from improper use. Classifications include:

  • Class I. Non-electric items from bandages and handheld surgical tools to wheelchairs and other low-risk items.
  • Class II. CT scanners, pumps for IV medications, and other intermediate-risk items.
  • Class III. High-risk, life-sustaining devices such as pacemakers and deep brain stimulators.

Is the label applied in a clean room?

Yes, the experienced professionals at Royal Label adhere to a very strict segregation process to ensure sterilization and quality. No matter what device we are printing for, we make certain the environment is sanitary.

What conditions is the label exposed to?

The conditions the label is exposed to depend on the specific product and the individual components of that product. The labels we produce are only exposed to elements as necessary to protect the sterilization and quality of the product they are printed for.

What chemicals is the label exposed to?

Just as the labels are only exposed to conditions that affect the product’s components, it depends on the device we are producing the label for. The medical devices we print labels for are used for a large range of needs, which is why the chemicals the labels are exposed to vary.

Are we printing variable data on the label?

With our Royal Label process, we can print GS1 barcodes, lot numbers, expiration dates, and any other data that you require. GS1 codes are important for reasons such as:

  • Supporting traceability of the product and helping in counterfeit prevention.
  • Minimizing the possibility of medication errors, as barcodes help differentiate between medications with similar names.
  • Streamlining recall measures by letting distributors and manufacturers accurately and quickly identify any products the recall affects.
  • Assisting clinical processes so that patient with multiple treatment offices have coordinated care when they are traveling or moving internationally.

What Is the Label Size and Quantity?

We work closely with our clients to meet the specs of the product. From the smallest medical component to the largest, our medical device label printing process can produce custom die-cut labels to fit your unique needs.

How Many Colors Can You Print?

In most cases, medical device labels are limited to one or two colors, but we can work with any design file to accommodate the range of colors requested. Our team always aims to exceed our client’s expectations with our label printing process.

How Can I Figure Out What Kind of Label I Need?

Royal Label is here to help you design and print the exact label you’re seeking. We are experts in FDA and GSI regulations and can help you achieve the correct labels printed to meet all federal and industry laws. The FDA requires quality assurance protocols to be put into medical device manufacturing processes to fulfill the Good Manufacturing Practice (GMP) requirements. This is simply another reason Royal Label ensures the highest quality of our labels.

Trust Royal Label for Your Medical Device Labeling Needs

If you are concerned about protecting your reputation by guaranteeing safety with the best medical device labeling in the industry, Royal Label is the company you can trust. We promise the finest quality labels for your products because we understand your reputation is as important to you as ours is to us. If you would like to schedule a consultation to discuss your medical device labeling needs, visit our website or reach out to us at (617) 825-6050.

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