Research & Development Engineering
Manufacturing
Regulatory Affairs Submissions and
Maintenance
Customer Service Outsourcing |
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| Research
& Development Engineering
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Large
and multidisciplinary medical device Engineering and Technician
staffs |
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Dimensional
and functional analysis |
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CAD
drawing |
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"Design
for manufacturability" product development approach
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Prototype
manufacturing |
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Expert
in the following materials |
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Polyethylene,
polyurethane, nylon, Peabax, FEP, Teflon (FEP, PTFE, ETFE)
Polycarbonates, composites, (PVC is being discontinued
due to DEHP concerns) |
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Elastomers
include polyisoprene, silicone, santroprene, etc. |
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Metals
include stainless steel, nitinol, titanium, platinum/iridium |
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Solid
modeling of polymers, elastomers rubbers, coatings and
metals |
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Verification
and Validation (V&V) for materials testing, biocompatibility,
simulated use for: |
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in
vitro testing |
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in
vivo testing (animal testing) |
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Project
Engineer dedicated to each development project |
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Quality
systems that meet all regulatory and GMP requirements |
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On-site
machine shop for quick turn around of needed parts and
fixtures |
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Web
and broad band video conferencing technology for customer
collaboration that supports teamwork, decreases development
costs and decreases time to market |
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Flexible
and transparent design transfer systems |
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Thomas
Medical Products, Inc. holds multiple 510(k)s, design
dossiers and technical files for its proprietary devices
that may be modified and applied to your product thereby
decreasing time to market |
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| Manufacturing
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to top >> |
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FDA-registered
medical device manufacturer, EN ISO 13485 and 13488 (Canada)
registered |
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Plasma treating,
pad printing, ultrasonic welding, radiofrequency tipping,
insert molding, joining, bonding, swaging, curving, medical
balloon, etc. capabilities |
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Six (6) 100,000 certified
clean rooms (10,000 certification available when needed) |
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Private label manufacturing
and labeling |
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Experienced Manufacturing
Engineers and Technicians |
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"Lean manufacturing"
processes and systems |
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Finished product manufacturing
and assembly |
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Bulk non-sterile product
manufacturing and assembly |
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Medical device
parts and pieces manufacturing and assembly |
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Packaging
that includes tray thermoforming, flexible pouches, preprinted
labels, inline printing, bulk non-sterile, and environmentally
friendly packaging |
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Sterilization
services |
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ERP system
that supports just-in-time supply chain management |
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(QA) Quality
Assurance processes and systems that meet all regulatory
and cGMP requirements and can be customized to support
each customers’ unique internal quality system specifications
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Warehouse
space available for customer inventory management and
shipping services |
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3 shifts operating
5 days per week |
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| Regulatory
Affairs Submissions and Services
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IDE, PMA,
510(k), CE mark, Japanese and other international regulatory
submissions and submissions maintenance services |
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Existing design
dossier and technical files on many proprietary devices
which can be used as predicate devices for faster regulatory
approvals on customers’ products |
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Quality Assurance
systems and certified personnel to support reliable, fast
and accurate regulatory reporting and follow up |
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| Customer
Service Outsourcing
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Contract services
for clients wanting to decrease infrastructure and costs
associated with managing, equipping and building a customer
service organization on their own |
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In-bound telephone order
taking by professional staff using a dedicated 800 line
for each client that is answered with the client’s
name. Thomas Medical Products, Inc. is transparent to
the caller. |
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Web based in-bound ordering
using a link from client’s website to Thomas Medical
Products, Inc. The end user making the order only sees
the client’s name, Thomas Medical Products, Inc.
remains transparent during web transactions |
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Invoicing using clients
letterhead |
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Direct shipping of client’s
product to ordering end user |
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Daily new order and order
in process reporting to Customer Service Outsourcing clients |
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| Ask
us a question at info@thomas-medical.com
or call us at 866.446.3003 or +1.610.296.3000. |
