Healthcare/Life Sciences

Conceptualize
Design
Commercialize
T H E
Manufacture
Fulfill
Sustain
Healthcare/Life Sciences
L E A D E R
MID-LOW VOLUME, HIGHER COMPLEXITY
DIAGNOSTICS
MONITORING
SURGICAL
IMAGING
GLOBAL HEADQUARTERS
One Plexus Way | PO Box 156
|
Neenah, WI 54957-0156
|
www.plexus.com
AMERICAS
EUROPE
ASIA PACIFIC
+1 920 722 3451 Phone
+1 877 733 7260 Toll-free
+1 920 751 5395 Fax
+44 (0)1573 223 601 Phone
+44 (0)1573 223 600 Fax
+604 632 1000 Phone
+604 632 1888 Fax
Healthcare/Life Sciences
Conceptualize
THE BODY OF EVIDENCE
Intracranial Pressure Monitors
Ophthalmic Surgery
CPAP Systems
Ventricular Assist Devices
Cardiac Monitoring/Telemetry
Design
Commercialize
Manufacture
Internal Cardiac Defibrillator
Breast Biopsy Systems
Cosmetic Laser Systems
Dialysis Systems
Nutritional Pumps
MANUFACTURING SOLUTIONS
Plexus has delivered optimized Product Realization solutions through a unique customer
focused service model since 1979. This service model seamlessly integrates product
conceptualization, design, commercialization, manufacturing, fulfillment and sustaining
services to deliver comprehensive end-to-end solutions to customers in the Americas,
European and Asia Pacific regions.
Plexus is a leader in manufacturing mid-to-low volume,
higher complexity Class II and Class III medical products.
With more than 30 years of experience, Plexus has the
quality and regulatory expertise to meet the compliance
requirements and challenges of the healthcare and life
sciences industries. Plexus ensures that each product
is produced in the most cost-effective manner while
focusing on product quality and on time delivery. Plexus
will build, test, package and ship products to your
warehouse, into distribution or directly to your customer
from QSR compliant/ISO 9001 certified facilities.
Plexus is a leader in providing global engineering and manufacturing solutions to the
healthcare and life sciences industries through its ISO 13485 certified and FDA registered
global facilities. Plexus has successfully partnered with the world’s leading healthcare and
life sciences companies to deliver a wide range of Class II and Class III medical products
into the imaging, cardiovascular, monitoring, diagnostics, life sciences, therapeutics, clinical
diagnostics, laboratory diagnostics and prescription management markets.
Insulin Pumps
Continous Glucose Monitors
BPH Treatment Devices
Incontinence Treatment
Blood Gas & O2 Monitoring Systems
Glucose Meters
Orthopedic Surgical Tools/Monitors
Electro Surgery Devices
Clinical Lab Equipment
Wound Management
ENGINEERING SOLUTIONS
Plexus is committed to design excellence. Its experienced personnel of electrical,
mechanical, software and quality engineers are focused on the challenge of bringing
medical products to market. Plexus offers the technical expertise, processes and tools
necessary to develop and test devices that achieve functional, safety, efficiency and
unit cost product requirements. Plexus engineers leverage their depth of experience
and focus on Design for Excellence (Dfx) to improve project schedule predictability and
minimize product development risk.
Drug Delivery Devices
Medical Imaging
CUSTOMIZED SUPPLY CHAIN SOLUTIONS
Bedside Monitors
Pain Management Systems
MRI Image Enhancers
Ultrasound Imaging Systems
Ultrasound Osteoporosis
Devices
Sustain
WORLD LEADER IN PRODUCT REALIZATION
Atrial Fibrillation
Automated External Defibrillator
Fulfill
The development of Plexus materials management and supply chain solutions is based
on understanding and modeling the customers’ needs for efficiency and flexibility while
controlling total cost and materials liability. The core building blocks of Plexus supply
chain design are its proprietary analysis, design and simulation tools. Plexus determines
tactical methods to best fit every supply chain element by using these tools to design
and model global supply chains that consider the customers’ variability, flexibility and
service level requirements.
Cardiac Monitor
Ultrasound Imaging
The cardiac monitor is a portable,
AC-powered, home use medical
appliance that is used to interrogate
implanted cardiac-assist devices
and communicate with a proprietary
network. Plexus provides a full array
of services for this product, from
product conceptualization to
volume manufacturing and
sustaining services.
Plexus has provided design and
manufacturing services for cutting
edge ultrasound systems to leading
imaging OEMs for more than 30
years. These systems continue to
take a fresh look at ultrasound with
excellence in image quality, portability,
workflow and clinical care.
CONCEPT DEVELOPMENT
• System architecture
• Human factors/ergonomics
• Industrial design
• Concept convergence
PCB DEVELOPMENT
• PCB layout
• Design for fabrication
• Signal integrity
HARDWARE DEVELOPMENT
• Embedded board design
• FPGA design
• RF & wireless design
• Power supply design
Warranty and aftermarket services are available to
support the product throughout its life cycle. The
dedicated manufacturing transition team at Plexus
will facilitate the successful transition of your product
into its global manufacturing facilities, ensuring all
requirements are met.
MECHANICAL DEVELOPMENT
• Electronic packaging
• Structural optimization
• Thermal management
•Mechatronics
• Injection molded plastic design
RECOGNIZED LEADER IN
REGULATORY KNOWLEDGE
TEST DEVELOPMENT
• Test strategy/coverage analysis
• In-circuit test
• Functional test
Plexus provides support documentation for FDA
pre-market notification PMA and 510K, as well as
notified body submissions for CE mark compliance.
Plexus is a recognized leader in regulatory knowledge
and the application of international and domestic
safety agency requirements.
SOFTWARE DEVELOPMENT
• Embedded real-time system design
• PC application design
• Graphical user interface (GUI)
• IEC 62304 process compliant
DESIGN FOR EXCELLENCE
• Design for test
• Design for manufacturability
• Design for assembly
• Design for RoHS and REACH
Nucleic Acid Purification System
The Nucleic Acid Purification system provides high
throughput, automated purification of DNA from
biological samples. Plexus provided comprehensive
design and manufacturing solutions for this product and
delivered a functional prototype in just twenty weeks.
Experience on this system and others have included
sample preparation, assay automation, detection,
disposable interface and development. Plexus has a broad
range of life sciences experience for applied testing, IVD,
molecular diagnostics and clinical laboratory applications.
MANUFACTURING SOLUTIONS
• Global manufacturing facilities
• Printed circuit board assembly
• System integration
• Higher level assembly
•Mechatronics
• Surface-mount technology
printed circuit boards
• Plated-through-hole circuit boards
• Global supply chain solutions
• Obsolescence management
• Counterfeit parts prevention
•Microelectronics
• Manufacturing test support
• Component traceability
• Configure to order
• Direct order fulfillment
• Device history file
• FDA registered, QSR compliant
SUSTAINING SOLUTIONS
• Life cycle management
• Product revitalization
•Repair
•Refurbishment
•Replenishment
• Logistics optimization
QUALITY/REGULATORY
• ISO 9001
• ISO 13485
• 21CFR Part 820
• FDA Class II, III
• ISO 14001
• CE Mark
• EN 46001
•SFDA
•JGMP
DESIGN ASSURANCE
• International agency compliance
• Reliability engineering
• Product risk management
• Manufacturing transition & sustaining
Plexus designs and builds
each product as if the life of
a loved one depended on it.
Conceptualize
Design
Commercialize
T H E
Manufacture
Fulfill
Sustain
Healthcare/Life Sciences
L E A D E R
MID-LOW VOLUME, HIGHER COMPLEXITY
DIAGNOSTICS
MONITORING
SURGICAL
IMAGING
GLOBAL HEADQUARTERS
One Plexus Way | PO Box 156
|
Neenah, WI 54957-0156
|
www.plexus.com
AMERICAS
EUROPE
ASIA PACIFIC
+1 920 722 3451 Phone
+1 877 733 7260 Toll-free
+1 920 751 5395 Fax
+44 (0)1573 223 601 Phone
+44 (0)1573 223 600 Fax
+604 632 1000 Phone
+604 632 1888 Fax