mINNEAPOLIS-BASED PAD PRINTING SOLUTIONS FOR MEDICAL STARTUP COMPANIES

Easing the Costs of your Startup with Quality Pad Printing Solutions

We are here to help your Medical Startup Company turn your innovative ideas into real-world solutions. Here at UniversalPromo, we understand medical product development involves significant investments of both time and money. That is why UniversalPromo proudly offers customer-focused, customized pad printing services that substantially reduce expenses related to staffing, training and equipment for Medical Startup Companies.

In our work together, UniversalPromo remembers your medical product is ultimately patented, designed and developed to impact patients’ lives. We remember your end users in our work and adhere to industry standards for FDA approval processes. Medical Startup Companies can depend upon 40 years of experience to provide knowledgeable and efficient pad printing solutions. UniversalPromo’s team includes an expert staff, based in Minneapolis, who support the printing process from design to production.

We are a team of graphic design professionals, engineers, print operators, and customer service representatives who apply UniversalPromo’s values of fidelity and compliance to every project, every step of the way. We want you to experience the very best we have to offer. We promise your project will be completed with care and efficiency using state-of-the-art printers, supplies and design programs.

Communicating Your brand with Designs that meet your Aesthetic

UniversalPromo’s graphic design professionals help Medical Startup Companies ensure their medical product makes sense for end users, and consistently communicates brand recognition. Our team of graphic design professionals work with customers early in the product development process to create print designs that suit their product’s unique aesthetic and functional requirements. We use cutting-edge programs such as the Full Adobe Suite and Corel Draw to create designs that suit an array of substrates, so your brand can appear on a variety of products.

We’re here for all of your graphic design needs. For Medical Startup Companies that require additional graphic design services, we offer corporate identity kits that include logos, letterhead, instructional training materials, banners, posters and more.

Accomplishing even the hardest printing tasks with our in-house team of engineers

Medical Startup Companies engage in the hard work of product vision and revision. UniversalPromo knows that unique medical product designs require unique printing solutions! For small and large scale projects alike, our in-house Maple Grove, MN engineering team can adapt our printing equipment to accomplish diverse printing tasks. We employ time-tested techniques for effective and efficient printing jobs, using the best printers, pads, and medical-grade inks available. If your medical product has complex nooks and crannies that seem unprintable, fear not! We like a good challenge. UniversalPromo’s engineers specialize in converting two-dimensional designs to fit on three-dimensional surfaces. We are committed to ensuring your designs print cleanly on every curve and contour.

Class VI Medical grade ink pad Printing on a variety of substrates

At UniversalPromo, we employ a printing process for medical products called pad printing. This process uses customizable stamps to print clear designs on contoured or irregular surfaces. We use the very best machines and medical grade ink to meet branding and design standards for FDA approval. We print copy for Medical Startup Companies on an array of substrates that include the following:

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

We use Class VI Medical Grade inks for medical product printing. Our Class VI Medical Grade inks are high-quality inks suitable for a variety of medical applications. Our bio-compatible Class VI inks pass drug resistance testing and endure chemical, heat, and gas sterilization techniques. We can match these quick-drying, versatile inks to the color and opacity of your medical product.

FDA Compliant PRinting that won't compromise the integrity of your medical devices

One major challenge for Medical Startup Companies involves issues in the prototyping process related to compliance. Compliance issues can pose significant and frustrating delays in the medical product development process. At UniversalPromo, we want to see your ideas become solutions. We are mindful of the real-life impact your medical products hold for patients and healthcare professionals. That is why we will work with you through the printing process to eliminate unnecessary revisions and delays.

UniversalPromo is committed to preserving the integrity of your medical products during the printing process. We print in a clean environment, which involves careful control over factors that would compromise your medical product’s performance or safety. Our clean environments involve controlled factors such as personnel, equipment, air flow, and environmental conditions.

To prove your medical products have been compliant throughout the development process, UniversalPromo offers customers documented processes for their printing project. Documentation provides evidence of printing compliance for FDA standards. It also allows your printing project to be repeated or adjusted, should the need arise. Upon request, UniversalPromo also offers data sheets on material safety, as well as compliance certificates for all inks.

Prototyping and approval processes can be stressful. UniversalPromo is here for you. You can rely on our expertise to help navigate compliance standards for medical products. We’re here to support Medical Startup Companies as they bring great ideas to the healthcare industry.

UniversalPromo has industry experience spanning 40 years that includes printing solutions for Class I, Class II, and Class III medical products. Since 1976, FDA has classified medical products 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 recordkeeping 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.

Medical Startup Companies can trust UniversalPromo to meet all compliance standards required for printing on medical products, whether classified as Class I, Class II or Class III.

If you have any questions related to our design, engineering or printing services, please contact us. We look forward to working with you.