Contract Manufacturing

From concept development to large-scale cGMP manufacturing, we can help
get your product to market. From the largest medical companies in the world to small start-up companies, our dedicated engineers and personnel develop and launch products for numerous companies annually.

Kensey Nash's 202,000 square foot facility holds in excess of 20,000 square feet of Class 100,000/ISO Class 8 cleanrooms for manufacturing and clean packaging. With lot sizes ranging from less than 10 to over 10,000 pieces, we manufacture over 4.5 million medical components annually. These components can be used worldwide in orthopaedic, spinal, general surgery, cardiovascular and other applications to facilitate healing and bone growth, and provide support after surgery.

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.