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Metal Finishing Systems Inc

Exton, Pennsylvania

10-20

Metal Finishing Systems provides complete Product Design, Development, and Manufacturing for Sheet Metal Components and Assemblies from Prototype through Production Quantities. Our integrated sheet metal services are primarily focused on meeting the requirements demanded by smaller production runs. Our fast, quality service is backed by our satisfaction guarantee that your product will be made to your exact specifications. 25 years experience and the latest computerized equipment allow us to manufacture virtually any metal product product that you need.

Nugent Associates, Inc.

Exton, Pennsylvania

10-20

Nugent Associates, Inc. is located in Exton, Pennsylvania, United States and specializes in manufacturing the following processes: Die Casting, Injection Molding, Machining.

Kensey Nash Corporation

Exton, Pennsylvania

200-500

Kensey Nash Corporation is located in Exton, Pennsylvania, United States and specializes in manufacturing the following processes: Electro-Mechanical Assembly, Wire Harness, Rotational Molding, Structural Foam Molding, Fabrication, Injection Molding, RTV Molding, Compression Molding, Machining.

Kensey Nash Corp.

Exton, Pennsylvania

Job Shop / Contract Manufacturer

200-500

Metal & Plastic Machining

 

The Kensey Nash manufacturing team includes design and quality engineers, CNC programmers, machining technicians, and toolmakers. We offer seamless ""Art to Part"" manufacturing using design programs that allow us to efficiently produce our devices based upon customer requirements.

 

Our dedicated cGMP-compliant implant manufacturing space includes CNC Swiss- turn lathes, conventional CNC lathes 5- axis mills, laser marking and high-resolution measurement equipment. 

 

Medical grade materials routinely machined by us include:

Metals

  • Titanium 
  • Stainless steel
  • Tool steels
  • Cobalt-chrome
  • Tantalum
  • Tungsten

Plastics

  • Polylactides (PLA) 
  • Polyglycolides (PGA) 
  • Polycaprolactones (PCL) 
  • Polyetheretherketone (PEEK)
  • Acetal 
  • Polysulfone 
  • Polythermide
  • Polycarbonate 
  • Acrylic
  • Polypropylene 
  • PTFE 
  • Copolymer and composite formulations

Custom Tooling

 

Kensey Nash has an in-house design and fabrication tool and die machine shop fitted with state-of-the-art equipment that enables us to fabricate tooling for the production of micro-sized medical components with optimized dimensional resolution and surface finish.  Our toolroom is fully equipped with 3, 4 and, 5 axis CNC Mills, CNC Lathes, CNC Swiss-Turn Lathes, Wire and Ram EDM equipment along with conventional milling, turning and grinding equipment.

 

The services routinely provided by our staff of designers, toolmakers, mold makers and, machinists include:

  • Custom die fabrication of device prototypes
  • Construction of custom molds, fixtures and gauges
  • Development and production of surgical instruments and kits
  • Specialty tooling and test fixturing

 

Quality Assurance

 

Kensey Nash offers a broad range of quality and regulatory support capabilities. Our quality assurance group is comprised of over forty professionals who set standards, write and review operating procedures and protocols, monitor production and perform final mechanical and chemical testing of sample devices in over 7,000 square feet of laboratory space.

 

Certified and Accredited

 

Kensey Nash is registered with the US FDA as a medical device manufacturer and our quality management system is certified to ISO 13485.

 

Home » How We Partner » Contract Manufacturing » Device Fabrication and Assembly Assembly & Packaging

Kensey Nash has been fabricating and assembling devices for over thirteen years. During this time we have designed and developed FDA and CE Mark-approved medical devices. We are an ISO 13485 certified and FDA-registered manufacturing facility and produce approximately 4.5 million resorbable product units annually. We specialize in:

  • Fabricating products from raw materials, to fully packaged and sterilized in a turn-key format
  • Providing materials in a sub-assembly form to allow you to complete the final assembly
  • Providing fully packaged and/or sterilized product using customer materials

 

 

Capabilities

We have the following personnel and facilities to support your manufacturing needs:

  • 202,000 square foot facility built in 2006 with integrated Class 100,000 / ISO Class 8 Clean Rooms
  • ISO:13485 and FDA compliant
  • Production staff of approximately 75 technicians to assemble, test, inspect and package products
  • Product development and commercialization managers and engineers who help customers bring their concepts to the market
  • Manufacturing engineering staff that is experienced in tooling, automation, project management, device fabrication, packaging and assembly
  • Provide custom packaging to meet any branding, marketing or production requirements
  • Utilize existing machinery or design custom machinery to meet your product or production requirements
  • A regulatory staff dedicated to ensuring FDA and ISO compliance
  • Our regulatory group submits numerous US and EU submissions annually
  • Quality assurance personnel who perform incoming, in-process and final inspections to assure full specification compliance on every lot of material received and shipped
  • Sterilization validations, process validations, test method validations, ship and shake and packaging validations

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