Specialty Printing For Medical Engineering

Medical Engineers depend on UniversalPromo for printing solutions that bring medical device designs to life. Our expert staff uses state-of-the-art pad printers and time-tested processes that save Medical Engineers thousands of dollars during the design development process. You can be sure that your product is printed to uphold the industry’s most stringent design and safety standards.

Since our earliest days in business, our customers have remained our focus. We consider fidelity and compliance to be the pillars of our business, and these values guide our work on every project. You can trust UniversalPromo’s team of graphic designers, engineers, print operators and customer service representatives to offer consistent care for every project. That is what makes UniversalPromo a leader in the medical device printing industry.

As industry leaders, we understand the challenges Medical Engineers face during the medical device development process. Issues related to compliance and efficiency can pose significant delays in production and FDA approval. You can count on UniversalPromo to take time to understand the requirements of your product, so that we can complete every printing job the right way, on time.

CUSTOMIZABLE PAD PRINTING WITH QUALITY CLASS VI MEDICAL GRADE INKS

UniversalPromo uses a printing process for medical devices called pad printing. This customizable printing process results in high-resolution prints on curved, contoured and irregular surfaces. Using the highest quality printing machines and medical grade inks, we can transfer graphics and copy onto several substrates that include:

• Polyurethane
• Polypropylene
• Polyethylene
• Metal
• Glass
• PVC
• Pebax ^®

We protect the integrity of your medical devices by printing in a clean environment with Class VI Medical Grade inks. Class VI Medical Grade inks pass tests for bio-compatibility and drug resistance. These quick-drying inks are suitable for a variety of medical applications. The inks dry quickly and safely, enduring sterilization treatments such as chemical, heat and gas. UniversalPromo uses the latest color-matching technology to meet your specifications for color and opacity on medical devices.

CLEAN ROOM PRINTING PRACTICES AND AVAILABLE DOCUMENTATION IN COMPLIANCE WITH CLASS I, CLASS II, CLASS III MEDICAL DEVICE FDA STANDARDS

niversalPromo brings expert knowledge of compliance requirements to your printing project. We are committed to eliminating unnecessary delays in your medical device’s development process. You can depend on us to print your medical products holding the industry’s highest safety standards in mind.

Development of medical devices for the healthcare industry requires demonstrable, safe printing practices. Medical Engineers can trust Universal Promo to preserve the integrity of your medical devices by printing in a clean environment using the safest practices and equipment. Our clean room environment includes careful management of personnel and equipment processes; environmental conditions such as air flow; and routine, thorough cleaning.

To demonstrate safe printing processes for your medical device, UniversalPromo documents the printing process every step of the way. Customers receive documentation required for FDA approval of your medical device. Our documentation also ensures that your project is repeatable for future printing orders. If you need additional documentation, let us know. UniversalPromo will also offer material safety and ink compliance sheets upon request.

Our medical device printing experience includes multiple levels of FDA classification. Since 1976, the FDA has classified medical devices Class I, Class II and Class III “based on the risk posed by the device.”

Class I: General Controls. The FDA classifies Class I medical devices as low-risk to consumers. The FDA subjects Class I products to general controls aimed at establishing ongoing “safety and effectiveness” after devices are approved to market. General controls include the maintenance and evaluation of manufacturing, reporting, registration and record keeping processes.

Class II: General Controls with Special Controls. The FDA has determined Class II medical devices to present a greater risk to consumers than those categorized as Class I. The FDA applies the same General Controls to Class II medical devices as Class I. Additionally, they enforce additional Special Controls related to labeling, performance standards, and testing requirements.

Class III: General Controls and Premarket Approval. The highest medical device category is Class III. The FDA will classify medical devices as Class III if they “support or sustain life, are implanted in the body, or have the potential for unreasonable risk of illness or injury.” Because Class III devices pose the highest risk to consumers, these devices endure a higher standard for approval, including proof of safety and effectiveness. These products are subject to the same controls as Class I and Class II medical devices, and require premarket approval.