| MACDEE,
INC.
13800 Luick Drive
Chelsea, MI 48118-9588
USA
734-475-9165 (phone)
734-475-3825 (fax)
Web
Site
www.macdeeinc.com
Founded
1964
Contacts
Mark
Wellman
Vice President
markw@macdeeinc.com
Facility

18,000 sq. ft.
·
temperature-controlled
· nine acres
· 40 minutes west of Detroit Metro Airport
Staff
60 employees
Certification
FDA-registered/1983
EN 46002 Approved
ISO Certified
Focus
· CNC Machining of plastic implants and instruments
· Injection Molding of plastic medical devices
· Product Cleaning & Assembly
· Contract Packaging
Background
MACDEE
is a contract manufacturer of polymer-based medical devices,
specializing in the manufacture of UHMWPE orthopaedic implants,
plastic trials and instrumentation.
MACDEE was founded in 1964 as an injection molding company.
The owners eventually added machining capabilities to the
company to complement the successful injection molding business.
We subsequently became involved in manufacturing implants
for the orthopaedic medical device industry in 1974.
Years of experience have provided MACDEE with the expertise
to machine UHMWPE implants with a high degree of accuracy
and perhaps the finest surface finish in the industry.
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CNC
Machining From 5-axis milling capabilities to
live-tool turning centers with sub-spindles, we have over 27 pieces
of equipment to service virtually any aspect of our customers'
production needs. Since we only machine plastic, there is no risk
of cross-contamination from other materials. MACDEE has machined
a wide range of plastics, specializing in implant-grade UHMWPE.
We have fabricated products from all of the commonly used plastics,
most of the high-temperature resistant engineering plastics, and
even several biodegradable polymers.
Injection
Molding MACDEE built its foundation on injection
molding. We currently have seven presses, ranging in size from
30 to 150 tons of clamping force. We specialize in small to medium
volume runs, but can also handle high production volume demands.
Our presses can even be located within one of our several portable
Class 10,000 Controlled Environment Rooms for molding that requires
a high degree of protection from particulate contamination. We
have molded products and components from virtually every thermoplastic
resin that is used in the medical marketplace.
Product
Cleaning, Assembly & Packaging Product cleaning
and product assembly, using components we have fabricated as well
as those we purchase for our customers, is available to any of
our customers. Many of our product assembly operations are conducted
within our permanent Class 10,000 Controlled Environment Packaging
Room.
Finished
products and product assemblies are also packaged for sterilization,
using our pouch sealing, gas flush/vacuum sealing or blister sealing
equipment located within our Class 10,000 Packaging Room. Boxing,
labeling and shrink-wrapping services are also available within
our Packaging Department. These additional in-house capabilities
allow our customers to receive a product packaged and ready for
shipment to their sterilization source.
Quality
Assurance We are committed to shipping "zero
defect" products on time and at a competitive price. All
procedures and processes are controlled and documented according
to the most recent ISO and QSR guidelines. We have the right equipment,
including the latest CMM technology, and an experienced QC Department
to ensure that our customers will receive products that meet their
requirements.
Regulatory
Compliance MACDEE has been an FDA registered
contract manufacturer of medical devices since 1983. We are also
approved to EN 46002. Achieving these high standards demonstrates
MACDEE's ongoing commitment to our medical device customers.
Technology
We work closely with our customers to ensure their
final product can be made in a consistent and cost-effective manner.
With over 38 years of experience in the plastics industry, and
nearly 28 of those years serving the orthopaedic industry, our
engineering department understands many of the functional requirements
that may escape detection by others less experienced.
Once
your design is finalized, our proprietary process technologies
allow us to manufacture your product to exacting specifications
that meet and often exceed your requirements. Our state of the
art CAD/CAM systems are capable of IGES translation, solid modeling,
5-axis CNC code generation and off-line verification. All CNC
programs are centrally located and controlled to assure repeatable
performance over the product life cycle.
MACDEE's
technology investments include a state-of-the-art production control
system that provides automated material planning, scheduling,
data collection and costing. By planning material and production
requirements, analyzing real-time production information and costs,
we deliver products on time and at the best possible value to
our customers.
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