ABOUT

Marble Medical Inc.

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-layer laminations; 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:

  • Medical Patient Care
  • Surgical & Infection Prevention
  • Advanced Wound Care applications
  • Personal Care & Cosmetics
  • Veterinary supplies & diagnostics
  • Industrial applications including various niche markets

As a contract manufacturer, Marble Medical manufactures its customers’ – or their specification developers’ – products to their specifications. Our principal applications for contract manufacturing include:

  • General, non-active, non-implantable medical devices
  • Medical devices for wound care applications
  • Medical device components
  • Conversion of adhesive tapes and other substrates
  • Other support activities include specification consulting services assisting with customer product design and development, material sourcing, product prototyping, packaging, and sterilization management.

Marble Medical has successfully provided these services and served these markets since its founding in 1988.

Management

Design & Development

Our Services - MMI

Design & Development

At Marble Medical, we understand the importance of product design as it is the foundation for every end-product we manufacture.
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Manufacturing

Our experienced team is dedicated to developing a manufacturing process to accommodate the specific requirements of your product while meeting process quality and cost objectives.
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Product Distribution

In addition to helping you develop and manufacture your product, Marble Medical can assist you with your product distribution needs.
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Product Design & Development

Marble Medical is a contract manufacturer and, as such, its product design and development activities are limited to a review of its customers’ product design for manufacturing feasibility. In its capacity of a design specification consultant, Marble Medical can offer technical advice and/or suggest changes to its customers’ product design specifications for their consideration.

Marble Medical assists its customers in their product development by sharing its experiences and knowledge and by offering assistance in the following product development support services:

Concept development & product planning
Design review validation
Testing and verification methods development
Laboratory Testing Services
Sterilization Management Services
Raw materials & component sourcing
Cost targeting
Pilot Production and Prototype development

Packaging and Distribution
Certification & Regulatory compliance
Quality Assurance
Project Management
Validated process development within cGMP & regulatory guidelines
Process validation
Production test runs
Inventory and supply chain management

Manufacturing

Die cutting, Island Placement, Slitting, Laminating, Lot Coding, Embossing

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:

  • Precision Rotary Die Cutting to 16″ widths
  • Precision Flat Die Cutting to 20″ widths
  • Narrow-width Slitting
  • Multi-layered Laminations
  • Flexographic printing up to 7″ widths
  • Product Assembly Applications
  • Custom Packaging

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

Distribution

Supply Chain Management

Raw Material Feedstock

We manage the raw material needs of our customers for similarly used items upon which we can leverage our combined usages to obtain more efficient order quantities, shorter delivery timetables and lower pricing.

Raw Material Storage

Assisting our customers with the storage and inventory management of their raw materials which facilitates lower inventory levels, efficient order quantities, and lower overall material costs.

Logistics

In order to meet the supply chain requirements of our customers, Marble Medical offers expert logistical support ranging from warehousing finished product to their points of distribution within their supply chain via LTL freight, ground or overnight service.

Point-of-Sale

Customer support with order fulfillment through their B2B platforms.

3M Product Distribution

Marble Medical is a distributor for the entire line of 3M branded healthcare products.

Face Shields

Affordable protection for healthcare1, sanitation, industrial, and food service professionals. Marble Medical’s clear, one piece face shields are designed for protection against dust and liquids.


Directions

  1. Remove the protective film from the face shield. Note: The protective film is used to prevent scratching to the shield while in transit.
  1. Place the foam forehead cushion to rest comfortably above the eyebrows, and pull the tab through the square buckle until the Face Shield fits securely.

Product Specifications

DESCRIPTION
One Size Fits Most (circumference): 20″ – 25 1/8″
Shield Dimensions (L x W): 9″ x 13″
Open cell foam forehead cushion
Anti-fog coating – Non-sterile – Not shatter proof – Latex free

SHIPPING
Protective film prevents scratching while in transit
200 units per carton (24″ x 24″ x 14″)

PRODUCTION CAPACITY
10,000 / week

PRICING
$1.90 / shield (Volume pricing available)

MINIMUM ORDER
200

1 This face shield is intended for single use by a single user for medical purposes.  The product has not been cleared or approved by the FDA.  The FDA has authorized the use of this product by healthcare providers as personal protective equipment (PPE) under an Emergency Use Authorization (EUA) for the duration of the EUA. See https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe.

All materials sourced and fabricated in the U.S.A.

Quality

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 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.


Marble Medical’s Certifications

Find Marble Medical on the list of
3M Preferred Converters

FDA Registered Drug & Medical Device Contract Manufacturer - cGMP Compliant

 FDA Number:  1053428


ISO 13485:2016 Certified
Certificate Number:  C2018-02226

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