Business Details
Precision Medical Device Manufacturing Partner
Paragon Medical has been a trusted partner in the medical device industry for decades, dedicated to accelerating the development and production of high-precision components and systems. Our expertise spans implants, surgical instruments, and drug delivery solutions, supported by FDA-registered facilities and ISO-certified cleanrooms. We collaborate closely with healthcare manufacturers to refine designs, ensure regulatory compliance, and optimize cost-efficiency. With a global presence across North America, Europe, and China, we provide end-to-end solutions from concept to commercialization. Our teams combine technical innovation with deep industry experience to deliver reliable, cutting-edge products.We prioritize quality at every stage, utilizing advanced technologies like additive manufacturing and CNC machining. Our commitment to sustainability and operational excellence ensures clients receive both superior components and comprehensive support. By integrating design, prototyping, and large-scale production, we help bring life-saving medical innovations to market faster. Our focus on precision and reliability has made us a preferred partner for leading healthcare companies worldwide.
Services
Medical Device Manufacturing
Surgical Instruments
Orthopaedic Implants
Drug Delivery Systems
Additive Manufacturing
CNC Machining
Clean Room Assembly
Prototyping
Regulatory Affairs Support
Global Supply Chain Solutions
Highlights and features
- Decades of experience in medical device manufacturing
- FDA-registered facilities with ISO-certified quality systems
- End-to-end support from prototyping to commercialization
- Global manufacturing presence across three continents
- Expertise in advanced technologies like additive manufacturing
Associations and certifications
- FDA
- ISO 13485
- ISO 8 Class 100,000
Services
Medical Device Manufacturing
Paragon Medical designs and produces precision medical devices, including implants and surgical instruments, using advanced manufacturing techniques. Our FDA-registered facilities ensure compliance with stringent quality standards. We support clients from prototyping to full-scale production.
Additive Manufacturing
Our dedicated additive manufacturing facility enables rapid prototyping and production of complex medical components. With in-house HIP technology, we deliver high-precision parts for implants and surgical devices, reducing lead times and material waste.
Drug Delivery Systems
We develop and manufacture drug delivery systems, including auto-injectors and wearable devices, with precision components like springs and contacts. Our services cover design, testing, and assembly for reliable, patient-friendly solutions.
CNC Machining
Paragon Medical employs CNC machining to produce tightly toleranced components for medical devices. Our capabilities include 5-axis milling and Swiss turning, ensuring accuracy for critical applications like implants and surgical tools.
Regulatory Affairs Support
We assist clients with regulatory submissions, quality system implementation, and compliance strategies. Our team ensures adherence to FDA, ISO, and other global standards, streamlining the path to market approval.
Questions
What medical device manufacturing services does Paragon Medical offer?
Paragon Medical provides end-to-end solutions for implants, surgical instruments, drug delivery systems, and advanced surgical devices. Our services include design, prototyping, regulatory support, and large-scale production using cutting-edge technologies.
Are Paragon Medical's facilities certified for quality standards?
Yes, our facilities are FDA-registered and ISO-certified, including ISO 13485 and ISO 8 Class 100,000 cleanrooms, ensuring compliance with the highest medical manufacturing standards.
How does Paragon Medical support global clients?
With manufacturing locations in North America, Europe, and China, we offer regional supply chain solutions, reducing lead times and costs while maintaining consistent quality across all operations.
Can Paragon Medical assist with regulatory submissions?
Yes, we provide comprehensive regulatory affairs support, including FDA submissions and compliance strategies, to help clients navigate complex approval processes efficiently.
What advanced manufacturing technologies does Paragon Medical use?
We utilize additive manufacturing, CNC machining, laser technologies, and automated assembly systems to produce precision components tailored to demanding medical applications.
Reviews (1)
Sunshine
Jun 05, 2021
Report
If work there watch out for building 2 shipping is run by some who not on your on side if u are e not a drinker or think like she does you will not do well there. The employee are good hard work people and not a bad bunch of people but like any place watch ur back because no one else is
