Facility

Our 20,000 square foot facility includes a Class 10,000 cleanroom. Enova achieved registered firm status by the National Standards Authority of Ireland (NSAI) to hold ISO 13485:2000, ISO 9001:1994 and EN550:1994 certifications.

Cleanroom
Our facility offers a full spectrum of capabilities, which include a Class 10,000 cleanroom for manufacturing and assembly. Additionally, our personnel are trained in Class 100 manufacturing and aseptic fill procedures.

Accreditations
ISO 13485:2000 is a quality management system certification covering design control, manufacturing and distribution for best practices medical device manufacturing. Enova Medical Technologies’ certification covers sterilization of medical devices – validation and routine control of ethylene oxide sterilization. ISO 13485 benefits companies who want to place these sterilized devices in the European Union market.

ISO 9001 is a generic quality system standard applicable to many industries. For Enova, which designs, manufactures and assembles medical and in vitro diagnostic medical devices, and medical components manufacturers, this system ensures our customers that we have effective control over all aspects of our operation.

EN 550:1994 is a certification for the sterilization of medical devices, and for validation and routine use of Ethylene Oxide.
Enova Medical Technologies is registered for these certifications by the National Standards Authority of Ireland, Inc. (NSAI).

Testimonial

Enova’s manufacturing skills have enabled Disc Dynamics Inc. (DDI) to cost-effectively set up a Class 100 cleanroom at Enova. The cleanroom is used to develop and manufacture a portion of our DASCORÔ Disc Anthroplasty System that is now in clinical trials. Enova’s expertise in the medical industry, combined with their flexibility in working with DDI, were critical factors in our decision to select Enova as our outsourcing partner.

Ron Burke
Senior Vice President of R&D and Operations, Disc Dynamics, Inc.