Kensey Nash Corp.

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