enpath medical, inc
: overview : contract manufacturing : contract development
: Unison™ Steerable Sheaths (Deflectable Catheters)
Partnering with both small, start-up companies and industry giants, Enpath Medical has designed and developed an array of implantable stimulation leads covering a variety of clinical applications.

Enpath Medical's product development team draws upon 75 years of combined experience in CRM and Neurostimulation Lead design, development and manufacturing. This capability allows us to provide creative solutions to your product development challenges, while ensuring a timely, cost-effective, manufacturable and reliable commercial product.

Enpath Medical offers the following development service benefits:
development service benefits
Because Enpath Medical offers the full spectrum of product development services, OEM customers can utilize specific services in the development cycle, e.g., prototyping, testing, redesign, design verification, process development, etc. or they can use the entire spectrum.
Dedicated cross-functional project teams
Delivery of complete Design History File with verifications, validations, FMEAs, and Hazard Analysis
In-house regulatory submission support
Production scale-up capabilities for commercial manufacture
ISO 9001:1994/EN ISO 13485:2000 certified
Greatbatch, Inc.