Medical device realization.

We offer a unique capability; a combination of disciplines, process and deep medical expertise working in conjunction with our clients to bring devices to market in an expedient and accountable manner.

Expertise

Our people are our greatest asset with disciplines including research & strategy, human factors engineering and industrial design, six engineering specialties, advanced manufacturing, quality assurance and regulatory. Every project includes a core team comprised of these disciplines with the ability to bring in specialties as needed seamlessly.

Process

Our quality management system has been built from the ground up to meet the rigors of the FDA, include the best practices of project management, and innovation techniques while striving to be lean and nimble. Many clients utilize our system as a proxy for their own throughout the development process.

Proven Success

Few companies can match the capabilities of Ximedica. Whether used in part or whole, our integrated capabilities allow clients to bring a medical device to its first clinical trial or launch. Our combined experience has seen hundreds of successful devices enter the marketplace.

We understand the industry and its regulations. We understand that safety risks, business and technical challenges need to be balanced in order to bring innovations to market successfully and speed Return on Investment.

Ximedica is ISO 13485:2003 certified by the NSAI (National Standards Authority of Ireland) and FDA registered.

Click below to download the NSAI ISO Certification document.