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