Certified Quality Management ISO 13485 : 2012 2008 FDA RegisteredCertified Quality Management
ISO 13485 : 2012
ISO 9001 : 2008
FDA Registered

Custom Mold Design, Mold Building & Manufacturing of a Medical Biopsy Marker

At Marman Industries, we offer vertically integrated design, mold building, injection molding, assembly, and packaging services that build value into the manufacturing process. The product highlighted here is an instrument which is used to implant a marker at the biopsy site after a biopsy is taken. Because this product is used on patients in the medical industry, the customer sought out a manufacturing partner with ISO 13485:2003 certification and FDA registration. From the outset, we took on the project management role, which included providing engineering and design assistance to ensure that all parts would meet customer requirements as well as all regulatory compliance standards.

Once designs were finalized, molds were designed and built to manufacture the product in accordance to the customer's specifications. Having these abilities in-house allows us to have complete control over the fabrication process and shortens the time from development to production. ABS, polycarbonate, and polypropylene molded components were assembled under magnification to ensure precise assembly. The plastic sub-assembly components were injection molded to precision. Tensile testing was also performed to verify material strength.

The final assembly was packaged and sealed in preparation for shipping to a sterilization provider. The final design was delivered to the customer. We manufacture approximately 200,000 of these biopsy markers per year with weekly deliveries to the customer via a Kanban system. For additional details about this medical contract manufacturing project, see the table below, or contact us directly.

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Medical Biopsy MarkerMedical Biopsy Marker

Custom Mold Design, Building & Manufacturing Project Details

Project/Product Name
Dual Trigger Ultra Clip II, Biopsy Marker
Project/Product Description
Hand held device to implant a marker at a biopsy site, after biopsy is taken
Capabilities Applied/Processes
Primary: Mold Building, Injection Molding, Contract Manufacturing

Secondary: Validation, Packaging, Design Transfer
Equipment Used to Manufacture Part
Molds and Fixtures: EDM, CNC Milling, Surface Grinders
Parts and Assemblies: Injection Molding Machine, Package Sealing Equipment, Gluing machine
Overall Part Dimensions
10" long, 1" wide, ½" tall
Tightest Tolerances
+/-.002 Plastic, +/-.0002 Steel
Material Used
ABS, PC, Polypropylene
Material Finish
Textured to Highly Polished
In Process Testing/Inspection Performed
AQL Sampling, Tensile Testing
Industry for Use
Medical, Vascular
Volume
200K / year
Delivery/Turnaround Time
Daily Deliveries, Kanban System
Delivery Location
Georgia, Puerto Rico
Standards Met
ISO 13485, FDA Registration
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