Quality and responsiveness you can count on in the high-stakes, competitive global Medical market
Responsive Manufacturing & Supply Chain Solutions for Medical OEMs
The Medical Device & Healthcare Equipment market is intensely competitive, with Medical OEMs focusing significant resources on challenges such as globalization & IP protection, regulatory hurdles, cost containment, long lifecycle challenges, device security and, of course, patient safety and wellbeing.
Segue is a proven medical device manufacturing partner with medical experts in North America, China and - coming in Spring 2024 - Mexico.
We are ISO 13485-certified, FDA-registered and specialists in medical devices and large-format medical equipment.
From Overmolded Cables to 2,000lb Equipment, to Medical Device & Healthcare OEMs, Segue Delivers:
Supply Chain Risk Mitigation...Wherever Your Device Is Manufactured and Wherever It's Sold
Certified Medical manufacturing expertise, capacity, and fully developed supply chains in North America and Asia for cables, sub-assemblies and fully integrated final products.
Global Regulatory Expertise including in the USA & China
Segue's manufacturing operations are ISO 13485-certified and FDA-registered. Segue's facility in Xiamen, China, with its Class 10,000 Clean Room, also holds the MedAccred accreditation, with audit criteria developed by Boston Scientific, Philips, Medtronic, BD, Johnson & Johnson and Stryker.
Specialist Medical Device Manufacturing and Engineering Expertise
Segue's solutions for manufacturing and engineering Medical Devices are flexible, repeatable and to the highest quality, and are proven to accelerate the ramp from NPI to volume manufacturing, even during Covid.
Expert Communication & Responsiveness
Our engineering and manufacturing teams collaborate closely with our customers to deliver rapid responses while adapting to the medical industry's fluctuating demand and device requirements.
Would I recommend Segue Manufacturing Services? Absolutely, 100%, unequivocally, yes!
★★ Click to see why Medical OEMs choose Segue Manufacturing ★★
MedAccred Accreditation Dramatically Reduces Risk & Improves Product Quality for Medical Devices
Beyond ISO 13485... Is your EMS provider CERTIFIED to reduce risk while improving product quality for Medical Devices?
Segue Manufacturing Services' Xiamen manufacturing facility is!
Developed by elite Medical OEMs including Bausch Health, Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker, MedAccred® is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain.
In a nutshell, the program improves patient safety and product quality by verifying compliance with critical manufacturing processes improving the quality and consistency of medical devices.
Read more about Segue's MedAccred Accreditation in the MedTech Innovation News
Segue's Medical Device & Healthcare Equipment Expertise Includes:
- Operating Room Equipment
- Portable Patient Monitoring
- Imaging Systems
- Imaging Systems: CT, PET, MRI, X-Ray, Ultrasound, etc.
- X-Ray Microscopy
- Diagnostic Equipment
- Medical Waste Disposal
- Dermatology Systems
- Immunoassay Analyzers
- Respiratory Systems
- Ventilators
- Vascular Injection Systems – Drug and Dye Delivery
- Sterilization Equipment
- Laboratory Equipment such as Sequencing, Expression & Analysis Systems, Storage Systems
Segue Manufacturing Specializes in Medical Cable & Harness Assemblies, Overmolding & Complex Electromechanical Assembly
In addition to large-format electromechanical expertise, Segue is a leading medical cable assembly and wire harness manufacturer. We offer a full range of services for medical device cables, and are often able to effectively overmold assemblies that other manufacturers find difficult.
An essential part of almost any medical device, cables require expert engineering and fitting in order to provide the very best performance. We concentrate on providing not just exceptional components and services, but also on offering competitively priced delivery, using responsible sourcing. Our team can work flexibly with you on almost any project, complementing your in-house resources when it comes to working with medical device cables. Our OEM partners value our depth of knowledge of part design, mold tool design, mold materials and molding processes.
Medical Devices: Quality Certifications & Registrations
ISO 13485:2016
Segue ISO 13485 Certification - USA & China
Segue's manufacturing facilities in Boston, Massachusetts and Xiamen, China have the ISO 13485 Certification for Design Controls, Manufacturing, Documentation, & Quality Management System Standards
MedAccred
Segue MedAccred Accreditation
A group of Tier One Medical OEMs established MedAccred as a way to design in and prove rigor throughout the supply chain in medical device manufacturing. Segue's manufacturing facility in Xiamen, China was only the second company in all of China to achieve the MedAccred accreditation for Cable & Harness manufacturing.
Class 10,000 Clean Room
Segue ISO 7 / Class 10,000 Clean Room - China
Segue's Class 10,000 Clean Room enables us meet the stringent safety requirements for medical device and cable assembly and manufacturing.
FDA-Registered Manufacturing Facilities & Experience with End-Customer FDA Audits
Segue FDA-Registered Facilities - USA & China
Segue’s FDA-registered manufacturing facilities in the USA and China are expert in complex medical device electromechanical integration and cable and wire harness assembly.
IATF 16949:2016
Segue IATF 16949 Certification - USA & China
Segue's manufacturing facility in Xiamen, China is IATF 16949-certified. Although this standard reflects Automotive requirements, it's another indicator of the rigor of Segue's manufacturing processes.
ISO 9001: 2015
Segue ISO 9001 Certification - USA & China
Segue's manufacturing facilities in Boston, Massachusetts and Xiamen, China are ISO 9001-certified
Segue Manufacturing Quality Certifications, Registrations & Expertise
Looking for more info on all of Segue Manufacturing Services' Quality Certifications & our approach to ensuring quality and reliability for our customers?
>>Click here to learn more
Segue's Medical Device Capabilities
Medical Electronics Manufacturing Integration Specialist joins leading Medtech lineup as premier Medical conference returns to East Coast
For 30+ years Segue has been a trusted partner to Medical OEMs, evolving our offering in this market to include:
A Trusted Partner: Design Engineering and Process Expertise
- Segue has experience collaborating as an integrated design team member with medical suppliers to concurrently design complex cables and related sub-assemblies.
- We also collaboratively support our customers with their product manufacturability risk assessments and post-market vigilance requirements.
Medical-Focused Production and Program Management Capabilities:
- Material, process and test traceability as required
- Overmolded cable assemblies, smart cable assemblies and sub-assemblies with high reliability, medical device-specific connectors
- Delivery of low-to-medium volume cable assemblies and sub-assemblies from our Xiamen facility on a JIT replenishment basis from our US Distribution center
- Dedicated Program Manager for large projects providing a single point-of-contact
- Workforce trained to IPC-610/620, J-STD 001 and MIL-HDBK-454 standards
- Dedicated Medical Clean Room space to support clean manufacturing and packaging of medical components and subsystems
- Visual process procedures, dedicated tooling to ensure reliability and repeatability
- Wide range of testing capabilities from automated cable testing to full functional test on sophisticated, large-format box builds