Medical Device Printing for Designers and Manufacturers

Medical Device Pad Printing For Designers And Manufacturers

FDA Compliant Medical Device Printing In Alignment With Your Branding

UniversalPromo brings more than 40 years of industry experience to every printing project. Medical Device Design Companies rely on our expert Minneapolis-based pad printing services to advance their medical device concepts from prototyping to production that saves thousands of dollars in equipment, staffing and training costs during the design development process. Our expert staff uses cutting edge processes to brand medical devices that hold to the industry’s highest design and safety standards.

Though we take pride in the variety and quality of our services, we really celebrate the variety of our unique clients. Yes, we’re talking about you! We care about your particular printing needs for medical device designs. Our clients are core to UniversalPromo’s company values. You have been our focus from the very beginning. That is why we commit to uphold our values of fidelity and compliance for every client and every job. These are the pillars of our business. Our values made us industry leaders in medical device pad printing. Most importantly, our commitment to our clients has benefitted our clients!

We understand the importance of efficiency during your medical device’s development process. Our team of professional graphic designers, engineers, pad print operators, and customer service representatives will ensure the job is done right every time, on time. We guarantee it.

PRINTING YOUR COPY ON ANY SUBSTRATE WITH MEDICAL GRADE INKS

UniversalPromo completes medical device design printing using a printing process called pad printing. Pad printing involves imprinting three-dimensional surfaces with two-dimensional images. This printing process results in high-resolution prints on curved, contoured and irregular surfaces. We use top-quality pad printers and medical grade ink to transfer your logo and other information required for FDA compliance onto a wide variety of substrates, including the following:

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

We complete your medical device pad printing projects in a clean environment using Class VI Medical Grade inks. Class VI Medical Grade inks pass bio-compatibility and drug resistance testing, and are suitable for use in a variety of medical applications. Additionally, these inks dry quickly and prove impervious to sterilization techniques such as chemicals, heat and gas. We can match ink colors and opacity to products according to your specifications.

UniversalPromo documents processes for every job to ensure consistency and compliance with FDA standards. Upon request, we will provide our clients process documentation, material safety data sheets and certificates of compliance for all inks.

OFFERING A FULLY STAFFED GRAPHIC DESIGN TEAM TO ENSURE QUALITY PRINTS THAT ALIGN WITH YOUR BRAND

Well-designed corporate branding conventions ensure consistent and professional brand recognition. Our fully staffed graphic design team is ready to help you develop designs suitable for your medical device designs. Our professional designers utilize the latest tools in the design process, including the full Adobe Suite and Corel Draw. We specialize in the optimization of branding designs for compatibility with a variety of substrates, so your branding translates onto printed surfaces clearly and cleanly.

Our fully staffed graphics department works with clients early in the design process to develop quality artwork for your medical device designs. UniversalPromo’s graphic design team utilizes the most up-to-date color matching technology for pad-printed medical devices. The services our graphic design department offers include scanning, prepress and pre-production.

MEETING FDA COMPLIANCE STANDARDS IN PRINTING ON CLASS I, CLASS II AND CLASS III DEVICES

UniversalPromo’s expertise includes medical device pad printing in multiple categories of FDA classification. Since 1976, the FDA has classified medical devices as 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.

You can rely on UniversalPromo to ensure your product meets the FDA’s compliance standards for printing on Class I, Class II and Class III medical devices.

CLEAN ENVIRONMENT PRINTING AND APPROPRIATE DOCUMENTATION TO MEET FDA COMPLIANCE STANDARDS

UniversalPromo takes seriously our role in preparing medical device designs for FDA approval and consumer use. We understand the impact of delayed projects due to noncompliance with FDA regulations. You can expect us to do our part to ensure your products are printed compliantly and efficiently, every step of the way.

We guarantee all pad printing occurs in a clean environment, using the best quality machinery and medical grade inks for your medical device pad printing needs. Our clean printing environment prevents contamination of your product. UniversalPromo protects the integrity of your product during printing through superior control of processes related to personnel and equipment; environmental conditions; as well as routine and thorough cleaning. Controlling these factors prevents contaminants from compromising the safety and effectiveness of your medical devices.

To demonstrate compliance from start to finish, our clients receive documentation of our printing processes, as well as safety data sheets and certificates upon request. Documentation ensures our projects are repeatable, and your products remain compliant with FDA controls based on their classification.

We are here to support you as you support the integrity of your medical device designs, from the earliest stages of prototyping through manufacturing for market. If you have any questions about our Minneapolis pad printing processes or services, please don’t hesitate to contact us. We look forward to working with you to turn your ideas in high impact realities.