Medical Device Labeling

Medical Device Labeling

Proper medical device labeling is an essential element to any company that manufactures life science products. The labels and graphics that are placed on a device and its packaging materials and instructions are necessary to ensure proper use. This crucial step means users avoid the dangers involved with devices containing components that may cause allergic reactions.

Protecting patients from harm is the most important factor in medical device label printing. That is why Royal Label follows a very detailed protocol when printing labels for hospitals and medical facilities.

Satisfying FDA Regulations

The U.S. Food and Drug Administration (FDA) works under the authority of laws that congress has passed applying to medical devices, as well as other products like radiation-emitting electronics, biologics, and cosmetics. The laws define a label as a display of written, printed, or graphics on a product and its packaging.

Products start out as a concept that researchers, doctors, and engineers create when the healthcare market has a clinical need for a new medical device. It is critical to define and document specifics of device labeling at this early stage of the process. Occasionally, animal testing is needed before the product can move to human trials. The human testing that follows is referred to as the clinical trial and is used to determine whether the product is safe and effective for the purpose it was designed for. At this point, the device goes before the FDA for review. Once the FDA clears the device for approval, it is followed up by post market monitoring. This process monitors performance and side effects through surveillance reports specific to the device type.

The FDA requires that manufacturers of medical devices incorporate elements into their quality assurance programs that fulfill Good Manufacturing Practice (GMP) requirements of the Quality System regulation. This process ensures labeling meets legibility and adhesion requirements. It also ensures that labeling operations must issue and use correct labels.

Royal Label is a leading medical label printing company that creates high-quality labels for a vast array of products. Medical equipment and devices are carefully evaluated by the FDA before they go on the market. They categorize products into groups that have different labeling requirements for the healthcare industry.

The FDA uses a classification system that places items like non-electric wheelchairs, handheld surgical tools, and bandages into Class 1, as they are low risk devices. Intermediate risk devices, such as infusion pumps for IV meds, and CT scanners are Class 2, and high-risk items like deep-brain stimulators and pacemakers are placed into Class 3. These devices are essential to sustaining life.

Our Medical Device Labeling Products

We produce custom labels for medical devices in each of the three classes that the FDA categorizes the products into. Labeling is important, as the FDA requires strict adherence to classification requirements. Some of these devices include ventilators and life science applications equipment, as well as medical packaging and Information for Use (IFU) materials.

IFUs are one of the most vital items that accompany medical equipment. They detail the proper application methods for the medical products to ensure no careless mistakes are made when put into use. Compliance with FDA guidelines is essential to prevent injury or death due to improper use. We adhere to all product specific labeling requirements and quality system procedures.

We Pay Strict Attention to Our Standard Operating Procedure

At Royal Label, we understand the complexity of providing detailed labels to guarantee there are no errors that could cost precious patient lives. Our skilled professionals adhere to a zero-defect policy to ensure the highest quality end product for your medical device labeling.

Our stringent lot segregation process is one of the ways in which we monitor the quality of our products. We have honed this production procedure to verify that the labels we produce for sterilized products is detailed and accurate. Our sterile device labeling products are designed to exceed the expectations of our clients. Whether the product that will face repeated washing, sterilization, and even extreme temperatures, we guarantee our labels can stand up to the wear and tear.

Sterile device labeling requires special attention to make sure users are aware of which components are meant to be kept sterile, as some medical devices are not entirely sterile. Some equipment, for example, may include a large processing machine with a tube or operational component that must be kept sterile. The labeling for these products should include any special cleaning requirements, limitations on the number of times the device may be sterilized or cleaned and still function effectively, and changes to the device that cleaning may cause. This is vital information, as these changes could affect the performance, effectiveness, or safety of the product.

If a product is intended to be a single use sterile device, it must have labeling stating that it should not be cleaned and reused, advising the user against re-sterilizing. Another detail that can’t be overlooked is packaging for multi-use kits that contain both sterile and non-sterile contents. The labeling should always state that not all contents of the package are sterile.

Royal Label Is a Trustworthy Manufacturer

We pride ourselves in being a company that our clients can trust for attention to detail that ensures the quality of the labels that accompany their devices. We implement best practices in managing the complexity of medical device labeling and adhere to GMP labeling and packaging requirements. These precautions guarantee your reputation in the competitive medical field and preserve our standing as an industry leader with over 60 years in the business.

Our professional team will work with you to guarantee that we print medical labels for your products that meet your high standards and expectations, in addition to satisfying all federal labeling requirements. For further information about scheduling an audit of Royal Label’s facility or how we can help you meet your medical labeling needs, please call Marychristine Clifford at (617) 825-6050 Ext. 105 or send an email to [email protected]. We look forward to being the company you turn to for all of your medical device labeling needs.

Sources:
https://jamanetwork.com/journals/jama/fullarticle/1817798
https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.rcri-inc.com/medical-device-labeling-best-practices/


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Royal's processes are built from a foundation of over 60 years of experience and hundreds of customer audits. We look forward to working with your QA team.