Medical Device

In the ever-evolving landscape of medical devices, precision, quality, and compliance are non-negotiable. ATL, a leading medical device contract manufacturer, stands at the forefront of innovation, providing customized solutions for disposable adhesive medical products and printed labels. ATL’s expertise and capabilities contribute to the success of top medical device companies and startups.

ATL's Manufacturing Capabilities for Medical Devices

1. Precision Rotary Die Cut Components

ATL specializes in manufacturing precision rotary die cut components. These intricate pieces play a crucial role in medical applications, ensuring seamless functionality and reliability. From wound care products to diagnostic devices, our precision engineering ensures consistent performance.

2. Complex Multi-Layer Laminations

Medical devices often require multi-layer constructions for enhanced functionality. ATL excels in creating complex laminations that combine various materials, adhesives, and substrates. Whether it’s a wearable sensor or a drug delivery system, our laminations meet the highest standards.

3. Narrow Web Converting and Flexographic Printing

Our narrow web converting capabilities allow us to produce labels, tapes, and other components with exceptional precision. In-line flexographic printing ensures vibrant, durable graphics that convey critical information to end-users. ATL’s labels are not just informative; they’re an integral part of the user experience.

4. Island Placement and Kitting

Island placement involves strategically positioning adhesive islands on a substrate. Whether it’s for wound dressings or electrode pads, ATL’s expertise ensures optimal placement for functionality and comfort. Additionally, our kitting services streamline assembly processes, saving time and resources.

5. Packaging and Contract Manufacturing

ATL’s commitment extends beyond component production. We offer comprehensive packaging solutions tailored to each product. Our contract manufacturing services cover everything from assembly to final packaging, ensuring a seamless transition from production to distribution.

Quality and Compliance

ISO Certification

ISO 13485:2016: ATL adheres to ISO 13485 standards, emphasizing quality management systems specific to medical devices. Our processes undergo rigorous audits to maintain certification.

FDA Compliance

FDA Regulations (21 CFR 820): We strictly follow FDA regulations for cGMP compliance. From material sourcing to storage, every step aligns with industry best practices.

Clean Room Facilities

ATL operates in ISO Class 7 and ISO Class 8 certified clean rooms. These controlled environments minimize contamination risks during manufacturing, ensuring the integrity of your medical products.

Documentation and Traceability

Our quality management system meticulously documents materials, processes, and inspections. Traceability is essential for accountability and regulatory compliance.

 Product Application Examples:

When it comes to medical device manufacturing, ATL is more than a supplier—we are a strategic partner. We collaborate with you to develop, manufacture, and launch innovative products that improve patient outcomes.