In the medical device industry, labeling is crucial for patient safety, regulatory compliance, traceability, and more. Improper or poorly designed labels can open up manufacturers to severe legal liability, regulatory sanctions, product recalls, and increased safety risks.
When you are choosing a provider for medical device labeling, you need the experience and expertise of a company like Tapecon to meet the most stringent requirements.
Essential Regulatory Requirements for Compliance
To ensure patient safety, medical device labeling solutions must meet strict guidelines. Here are just a few of the compliant medical device labeling requirements:
- The U.S. Food and Drug Administration (FDA) mandates clear labeling to ensure patient safety. Compliance with 21 CFR Part 801 and Part 820 is essential.
- Unique Device Identification (UDI) compliance for medical devices enables traceability and recalls.
- ISO 15223-1 provides symbols and terminology for medical device labeling.
Medical label printing also has to adhere to global standards to ensure compatibility with regulations to allow market access.
Common Labeling Challenges in Medical Device Manufacturing
Medical device manufacturers must go beyond meeting minimal compliance and this means overcoming challenges in production. Labels must often withstand harsh conditions. Beyond heat, cold, and moisture, devices must also stand up to sterilization processes and remain legible.
Printing must also adapt to a wide range of substrates, coatings, and adhesives with exceptional adherence.
Expertise in Medical Device Labeling
Tapecon has more than 100 years of manufacturing experience with deep expertise in durable printing and coating for medical devices to ensure high-quality, compliant labels.
Digital printing solutions are highly flexible to handle any volume without the need for plate setup. This reduces printing costs while enabling highly precise, readable, and durable labeling in our FDA-registered facility.
Traceability is a key requirement. With each device requiring unique identification, medical device labeling solutions can leverage Variable Data Printing (VDP) to create custom medical labels at the item level. This produces individual item traceability to meet regulatory compliance and enhance safety.
Tapecon also has expertise in designing medical device labels for customers, including the precise information needed to meet compliance and industry standards.
Medical device labels and decals must also catch the user’s eye to be effective. Tapecon can produce high-quality digital printing, membrane switches, and graphic overlays that improve the functionality and clarity you need while also helping to identify and brand your products.
Tapecon is also committed to green printing strategies, reducing waste, and optimizing energy consumption to reduce our carbon footprint.
Innovative Medical Device Labeling Solutions
Depending on your specific application, Tapecon can apply different technologies for medical device manufacturing and labeling.
Tapecon also produced printed sensing mats that trigger an alert when patients attempt to leave their hospital bed. Designed to aid in fall prevention, the client needed a cost-effective method to notify staff of patient movement. Screen printing conductive and dielectric inks onto a polyester film with custom snaps created a pressure-sensitive mat.
Whether you need medical device labeling solutions or innovative approaches to medical device manufacturing, Tapecon has the experience to solve complex problems and produce exceptional solutions.
Future Trends in Medical Device Labeling
As technology continues to evolve, there are emerging trends in medical device labeling that integrate advanced materials. Anti-microbial coatings are helping prevent infections. A wide range of substrates and more sustainable materials are also used to improve efficiency and sustainability.
Tapecon has the technological and industry experience to apply these cutting-edge techniques and more.
Customized Printing Solutions
The medical device printing and labeling partner you choose is crucial for your business. Tapecon’s expertise ensures high-quality and durable labels that meet compliance regulations and stringent industry standards. We apply tailored strategies to meet your goals, leveraging cutting-edge technology to produce the medical device printing solutions you need for even the most challenging applications.
LET’S MAKE SOMETHING GREAT
With over 100 years of manufacturing experience, Tapecon works with product teams to solve challenges, create products, and enhance lives. Learn more about our flexible printed electronics applications and contact Tapecon today to discuss your next project.
