Marble Medical provides custom development and manufacturing services for full product development, from early stage concepts to full-scale manufacturing. Marble Medical is a cGMP-compliant, ISO 13485:2016 certified partner for innovative solutions in the patient care, personal care, veterinary care, and industrial markets.

Marble Medical produces subassembly components and turnkey disposable devices from short runs to full-scale production. Development support capabilities include assistance with design validation, process development, materials sourcing, cost targeting, prototyping, inventory and supply chain management. Manufacturing capabilities include narrow-width slitting; multi-layered laminating; precision die cutting; flexographic printing; and clean room production & packaging.

Clients and Markets Served

Marble Medical serves a global customer base of major medical product companies and industrial manufacturers and assemblers. We specialize in serving customers who have needs in the areas of product development consulting, manufacturing, assembly, and packaging.

Recognized by 3M™ as a Preferred Converter, Marble Medical serves the following markets:

Marble Medical operates in a 12,000 square foot climate controlled, FDA registered production facility. The production area includes white room (non-classified) production areas and clean room production capability up to Class 100,000.

Marble Medical manufactures all of its production in accordance with the requirements of its Quality Management System and the corresponding requirements of its ISO 13485:2016 certification along with the FDA’s Quality System Regulations (21 CFR Part 820), as required. Marble Medical utilizes rotary die presses, flatbed presses, and various pieces of customized equipment for its converting, printing and packaging applications.

Converting Applications

Our primary converting applications include, but are not limited to:

If the application you require is not listed, please contact us to discuss how your idea can expand our capabilities.

Marble Medical maintains an established, documented, and implemented quality system appropriate for the scope of its activities.  This system meets the requirements of ISO 13485:2016; the FDA’s Quality System Regulations (21 CFR 820); and our customers’ individual requirements. In accordance with our Quality Policy, each member of the Marble Medical Team has committed to:

Meeting and exceeding the expectations of our customers
Meeting the requirements of our quality management system
Maintaining the effectiveness of our quality management system
Commitment to meeting the requirements of the regulations/standards
Continual improvement of our processes

Our success is determined through the use of measurable quality objectives that are periodically reviewed by management and communicated to all associates.

Complete traceability of each raw material component, personnel involvement and equipment used to produce every customer order is facilitated through a proprietary operating software system, which is an integral part of our operations.

Stringent audit oversight consists of our own internal audit function in conjunction with our quality process; ISO 13485 registrant re-certifications; regulatory agencies reviews; and customer audits.

We utilize our quality processes as a basis for continuous improvement. We are driven by our customers, our competitors, and most importantly, by our employees who recognize continuous improvement is key to our success and as a result, their livelihood.