Design
From voice-of-customer research through design verification, our engineering teams translate clinical needs into manufacturable implant designs.
Accelerating MedTech
Integrated OEM Solutions
Turnkey, regulatory-cleared systems that accelerate product launches.
From concept to global launch, one vertically integrated partner manages the full product lifecycle so you can focus on your market, surgeons, and patients.
Your Market Focus. Our Full Development Chain.
EXALTA manages the complete development and manufacturing lifecycle for OEM orthopedic partners. Our integrated model covers product design, regulatory clearance, manufacturing, and post-market maintenance under one roof.
This means your team stays focused on market insights, surgeon relationships, and patient outcomes. We handle every stage of bringing a new implant system from concept through global commercialization and long-term market support.
Lifecycle
Four Phases. One Integrated Partner.
We serve as an extension of our partners to bring innovative orthopedic solutions from design to market launch.
Develop
Regulatory strategy, global market authorizations, supply chain management, and clinical evidence generation from a single integrated team.
Manufacture
On-site manufacturing with Class 7 clean room capabilities, risk management, post-market surveillance, and continuous improvement.
Maintain
Post-market clinical follow-up, regulatory change impact assessments, market authorization renewals, line extensions, and redesigns.
Regulatory and Quality
Regulatory Clearance and Quality Integration
EXALTA maintains in-house regulatory and clinical teams that handle global submissions from strategy through post-market compliance. Our regulatory services include 510(k) writing and submission, EU MDR and UKCA compliance, global registrations, rebranding support, and change impact assessments.
Our clinical research team produces Clinical Evaluation Plans, Clinical Evaluation Reports, Post-Market Clinical Follow-up studies, and Summaries of Safety and Clinical Performance. For OEM partners managing acquisitions or portfolio transfers, our QMS integration team handles design history file documentation, gap assessments, and EU MDR-compliant quality system transfers.
Ready to Explore an Integrated OEM Partnership?
Whether you need a full product lifecycle partner or support for a specific development phase, our team is ready to discuss how EXALTA can accelerate your next product launch.