Commercial Manufacturing Phase
Upon regulatory approval of your product, Millar's production team will be ready to ramp up production to meet early-adopter demand. As your device achieves greater market penetration, our production team will expand with the product's adoption. Millar's OEM Partner Management Team stays in regular contact with your commercialization team to ensure we are ready to meet your growth requirements.
Millar Uses Proven Commercial Manufacturing Process
Medical Manufacturing Process Designed to Expand
Millar is not just your early development partner. We also are built to grow with you, helping optimize your product to achieve higher yields, reduced costs, and expanded capacity. We offer our OEM partners full-scale contract Commercial Manufacturing services in compliance with all current standards for medical device manufacturing, from pressure sensor integration components to fully assembled medical devices. As with any contract manufacturer, we will put a manufacturing agreement in place to define responsibilities and set both companies up for success.
Like many medical device products, yours likely launched as a generation-one device with future capability already in mind. Millar's OEM Solutions integration process can be restarted at any phase. Our team will be ready to tackle your generation-two device when you are.
Commercial Manufacturing Partnership Supports Compliance
Maintaining regulatory compliance is part of Millar's daily operation. We are an ISO 13485 certified medical device manufacturer operating an ISO Class VII clean room. With Millar-branded products approved for sale in the US, EU and Japan, we have the hands-on experience necessary to assess ever-changing regulatory requirements and ensure that our OEM partners' products and processes are always audit ready. This includes continuously monitoring the regulatory environment for changes to FDA and EU medical device regulation.
Quality product delivery is our top priority. Our regulatory and quality teams ensure our Quality Management System remains robust and adaptable to changing requirements and strives for continuous improvement.
Our Quality System is compliant to:
- ISO 14971
- ISO 13485
- FDA 21 CFR 820
Case Study
Codman Microsensor® ICP Transducer Revolutionizes TBI Treatment
Codman, now part of Integra LifeSciences, reached out to Millar OEM Solutions in 1990 to develop a better method for measuring intracranial pressure (ICP) in patients with traumatic brain injury (TBI). Millar's patented strain-gauge technology in the Codman Microsensor® ICP Transducer gives medical practitioners the precise, reliable information they need to intervene quickly and relieve brain-damaging pressure. To date, Millar has manufactured more than 1.1M units for Codman that have revolutionized TBI treatment.
Previous Step: Clinical Engineering
Millar's Clinical Engineering phase supports our OEM partners' submission, regulatory testing and clinical trial schedules. Our purpose in Clinical Engineering is to get your product through regulatory submission and approval, and into the hands of physicians faster. Come learn more about Millar's Clinical Engineering.
Next Step: Sustaining Engineering Services
After completing Commercial Manufacturing, your project will be eligible for the next step in Millar's OEM Solutions Integration Process -- Sustaining Engineering Services -- where we offer support to ensure the ongoing success of our OEM Solutions partners. Come explore Millar's Sustaining Engineering Services.
Contact Millar
Millar OEM Solutions has been collaborating with our partners for years to help create breakthrough products that shape the future of medicine. Contact us today to collaborate on your next project. We welcome your questions and ideas. US Headquarters T: +1 832.667.7000. Toll Free: 800.669.2343 (US Only)