Custom Products for In Vitro Diagnostics

… tailored consumablesunlimited In Vitro Diagnostic solutions

As your partner, we provide:• Extensive R&D capabilities

• Global footprint for localized manufacturing

• Product and process validation expertise

• Wide range of development and manufacturing technologies for plastic products

• Supply chain management proficiency

• Quality systems designed to provide support in meeting global regulatory standards

unlimited benefits

Your proven strategic partner for development and manufacturing in the IVD industryKnown worldwide for superior quality and

innovative products, you can depend on

Thermo Fisher Scientific to design, develop

and manufacture customized solutions tailored

to your exacting requirements.

As leaders in leakproof containment systems,

diagnostic surfaces and plastic materials, we

combine world class manufacturing with

industry-leading development practices to

deliver innovative system solutions with on - time

implementation and delivery.

what is our commitment to the diagnostic industry

Our clients know

. . . so what can we tailor for you?

YOUR NEXT PROJECT

Product requirement development

Product design collaboration

CAD models

Prototype models built

Product speci�cation - PFMEA

Pilot scale manufacturing

Product veri�cation and quali�cations

Product validation

Distribution

April May June July August September

Thermo Scientific Nalgene diagnostic leakproof bottles

and Thermo Scientific Nunc diagnostic products set

the standard for quality and innovation - and by

continuing to deliver leading solutions, we have

become one of the life science industry’s most trusted

partner.

Our design and development experience enables

you to deliver innovative solutions to your customer.

We are a high value development and production

partner for all aspects of of plastic custom products.

Optimize your opportunities

For more information on custom products for In Vitro Diagnostics, please visit: www.thermoscientific.com/oemdiagnostics

. . . so what can we tailor for you?

YOUR NEXT PROJECT

Product requirement development

Product design collaboration

CAD models

Prototype models built

Product speci�cation - PFMEA

Pilot scale manufacturing

Product veri�cation and quali�cations

Product validation

Distribution

April May June July August September

Reagent packaging & diagnostic devices• Leakproof container and closure systems

• Validated and certifed materials

• ISO 13485 quality system

• World class diagnostic components

• Expert guidance on surface selection

• Tailored for your application

• Exact solutions

decrease your time to market with proven development and manufacturing

unlimited capabilities

* Process Failure Mode Effects Analysis

Design• Industrial and human factors

• Mechanical engineering

• Design for manufacturabililty

• Proven IVD product experience

Development• Project management

• Prototype and pilot scale tools for design verification

• Plastic materials expertise to help drive innovation solutions for molded products

Manufacturing• Global manufacturing locations to

optimize your supply chain

• Cleanroom molding capabilities

• Broad plastic processing capabilities

• Automated assembly processes

• Surface modification/treatments

Validation• Quality process tools throughout project

development

• PFMEA* and risk assessment processes

• Complete validation documentation support

Regulatory support• Materials compliance to local

regulations

• Support documentation for your process analysis

General capabilities• Diagnostic assay and reagent services

that can be combined with our plastic custom consumable development processes

• Immunoassays

tailored solutions for your business

Contact us today

visit www.thermoscientific.com/oemdiagnostics

thermoscientific.com/oemdiagnostics © 2012 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. Specifications, terms and pricing are subject to change. Not all products are available in all countries. Please consult your local sales representative for details.

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