What We Do
Customers choose EXALTA because they need progress, not handoffs. Design, regulatory, manufacturing, and post-market — integrated so your program reaches scalable production sooner.
What We Do
Each capability is a structured knowledge object — linked to processes, products, and facilities. Update once, reflect everywhere.
From concept definition through design transfer — DFM, V&V, and platform technology access.
ISO 13485-certified production across 10 facilities. CNC, forging, additive, and finishing.
510(k), CE-MDR, UKCA pathway support. 150+ clearances as manufacturer of record.
Design control, process validation, CAPA, and post-market surveillance across all sites.
Global sourcing, nearshoring, strategic inventory, and logistics across 3 continents.
CAST team activation, complaint handling, field safety, and lifecycle management.
Design & Development
Most CDMOs wait for a finished design. EXALTA's R&D team embeds manufacturing and regulatory insight from day one — so your concept reaches clearance faster with fewer surprises.
Manufacturing
Your device moves from first article to sustained production without changing partners. Ten facilities, three continents, one quality system.
Regulatory Services
EXALTA offers two paths to market: access our portfolio of regulatory-cleared, private-label-ready implant systems and start selling in as little as 12 months — or co-develop a custom program where we hold the DHF, manage the 510(k), and stay accountable through post-market. Either way, you skip the years of regulatory groundwork.
How We Build
Multi-axis precision machining for complex geometries
Titanium and cobalt-chrome near-net-shape production
Additive manufacturing for implant prototyping and production
Anodize, passivate, blast, and coating processes
Clean room assembly, sterile packaging, and fulfillment
Quality & Compliance
Full DHF management from design inputs through design transfer and post-market surveillance.
IQ/OQ/PQ protocols with continuous monitoring across all production facilities.
CAPA, complaint handling, field safety corrective actions, and annual reporting.
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