From concept to commercialization, EXALTA delivers end-to-end design, manufacturing, and regulatory services for medical device companies worldwide.
Born from the strategic unification of industry-leading medical device companies, EXALTA brings together decades of engineering excellence, regulatory expertise, and manufacturing precision under a single, focused brand. We exist to accelerate every stage of the MedTech product lifecycle.
From initial concept to detailed design, our engineering teams transform clinical needs into manufacturable medical device solutions.
Learn moreRapid prototyping capabilities enable fast iteration, allowing you to validate form, fit, and function before committing to production tooling.
Learn moreComprehensive testing and validation services ensure your device meets all performance, safety, and biocompatibility requirements.
Learn moreNavigate FDA, CE, and global regulatory pathways with our dedicated regulatory affairs specialists who have secured thousands of clearances.
Learn moreState-of-the-art manufacturing across 12 global facilities including precision machining, injection molding, forging, and additive manufacturing.
Learn moreISO 13485-certified quality management systems with rigorous in-process and final inspection, ensuring every device meets the highest standards.
Learn moreWe sit at the center of the MedTech ecosystem, connecting the people and processes that bring life-changing devices from idea to patient.
Complete visibility and control over every stage of your product lifecycle, from design through delivery.
Sub-micron tolerances and advanced processes including 5-axis CNC, laser cutting, and additive manufacturing.
Integrated workflows and parallel processing dramatically compress timelines from concept to commercial launch.
Thousands of successful FDA and CE submissions. Our regulatory teams embed early to prevent costly surprises.
Design, engineering, manufacturing, and regulatory all under one roof means zero handoff friction and total accountability.
12 facilities across 3 continents with 1,500+ specialists, delivering consistent quality wherever your markets are.
Whether you are launching a new device or scaling an existing product line, EXALTA is your single-source partner.
We partner with the world's leading medical device OEMs to design, develop, and manufacture innovative solutions that improve patient outcomes.
Headquarters
Memphis, Tennessee, USA
Global Facilities
United States, Ireland, France, Malaysia
Email
info@exalta.com