Precision injection molding

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Extrusion

Moulding

Assembly

Precision injection moulding

Customised polymer solutions

RAUMEDIC – Your development partner and system supplier for medical and pharmaceutical assemblies and systems

RAUMEDIC offers a variety of production options for sophisticated and innovative customer requirements:

Æ Compounding

Æ

Prototyping

Æ Injection moulding

Æ Extrusion

Æ Assembly

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RAUMEDIC – Your specialist for customised injection moulding solutions

Æ

Precision injection moulding

Æ Silicone moulding

Æ Multi-component moulding

Æ Insert- and Overmoulding

Æ

Assembly

CERTIFICATE

The Certification Bo dy of TÜV SÜD Manage ment Service Gm

certifies that

bH

RAUMEDIC AG

Hermann-Staudinger

Str. 2

95233 Helmbrech ts, Germany including the sites

and scope of app see enclosure lication

has established and

applies a Quality Managem ent System.

70101220

An audit was perfo rmed, Report No.

quirements

Proof has been fur nished that the re according to

ISO 9001:2008

are fulfilled. The c ertificate is valid u ntil

2013-04-30

Certificate Registr ation No.

12 100 25775 TMS

Munich, 2010-06-

04

Page 1 of 2

QMS-TGA-ZM-07-

92

RAUMEDIC

Quality management

Æ

ISO 13485

Æ ISO 9001

Æ Appendix II to EC directive 93/42/EEC

Æ Appendix II to EC directive 90/385/EEC

Æ

Clean room production in accordance with ISO 14644, ISO class 7 (= 10,000)

Æ GMP standards

Æ CE-certification

RAUMEDIC

Material competence

RAUMEDIC processes all thermoplastics including high temperature materials as well as silicone.

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RAUMEDIC

Research and development

RAUMEDIC conducts continuous research on new materials, formulations and products. Research and development activities are conducted in our in-house laboratories.

RAUMEDIC continually searches for new innovations in polymer products using new or modified materials with improved or additional functional properties.

RAUMEDIC researches for innovative products:

Æ Basic research

Æ Product development

Æ

Process development

Æ Collaboration with universities and institutions

RAUMEDIC has extensive knowledge in these areas:

Æ Dehesive surfaces

Æ

Barrier functions

Æ Antimicrobial properties

Æ Anti-counterfeiting

Æ Hygroscopic polymers

Æ

Alternative materials

RAUMEDIC

Design

RAUMEDIC

Prototyping

Individual products demand differentiated approaches.

Depending on the requirements, optimum function of the products follows intuitive and ergonomic handling as well as customised appearance and feel. To achieve this we consider best design for manufacture and most economic manufacturing methods. Meeting your requirements is a pleasure for our experienced design engineers and product designers.

Our Interfaces:

Æ e3 / e2

Æ stp / step

Æ igs / iges

Æ dxf / dwg

It is often a long way from the initial idea to the finished product for serial production. The use of an effective prototyping is helpful in saving costs and time. With prototyping, RAUMEDIC offers the option of creating samples and small-scale series quickly and economically.

There are numerous options for:

Æ Stereolithography

Æ Laser sintering

Æ

Vacuum casting

Æ 3D printing

Æ Prototype tools

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RAUMEDIC

Precision injection moulding

Smallest dimensions, tightest tolerances and highest functional demands are customer requirements which RAUMEDIC fulfils in precision injection moulding.

We develop and produce customised moulded parts with component weights from 0.004 g to 200 g.

We produce high-precision injection moulded parts under clean room conditions using modern machinery. Our production processes are developed and validated by the use of suitable statistical processes.

Cannula holder for pre-filled syringes Application system for liquid drugs

Moulded-on catheter head for insulin applications Handset for laser operations

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RAUMEDIC

Silicone moulding

RAUMEDIC develops and produces single and multicomponent solutions to highest demands.

Our silicone specialists develop customised product solutions – from the initial idea to series production.

Features and benefits

Æ Platinum and peroxide silicone systems

Æ Long-term implantable

Æ All sterilisation types

Æ

Extremely long storage stability

Æ Good elastic and mechanical properties, resistant to deformation

Æ Complex shapes

Æ Thin walled designs down to 0.2 mm

Æ

Component weights from 0.03 g to 100 g

Æ Multi-component technology in hard-soft or soft-soft

Æ Overmoulding

Æ Surface modification

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RAUMEDIC

Multi-component moulding

The multi-component technology offers the ideal planning requirements for the development of new, innovative, medical and pharmaceutical products.

With this technology, RAUMEDIC produces moulded parts in thermoplastic polymers and silicone.

A large number of polymer materials can be combined and processed using the multi-component technology. This technology offers the possibility of combining various product features with low cost assembly.

Catheter coupling for regional anesthetics

Features and benefits

Æ Combination of various materials, hardness grades and colours

Æ Elimination of cost and time effective assembly

Æ Integration of several functions into one component

Æ Optimal coordination of individual components

Æ Sandwich moulding

Æ Assemblies with barrier function

Luer cannula for eye surgery

Drug container with barrier function

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RAUMEDIC

Insert- and Overmoulding

RAUMEDIC has expertise in extrusion and injection moulding as well as overmoulding. Overmoulding includes fully-automated moulding processes with tubing and metal components.

Overmoulding materials that are impossible to be glued together provide connections with greater tensile strength and better pressure tightness.

Luer cannula for eye surgery Overmoulded connector to a PVC tube for inhaler applications

Ruler guide for meniscus surgeries

Features and benefits

Æ

Manual, semi- and fully-automated handling of insert parts in the injection moulding process

Æ Optimal connection of individual components

Æ High seal requirements

Æ Automation

Æ

Customised testing and inspection processes

Æ RAUMEDIC assembly responsibility

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RAUMEDIC

Assembly

The diverse assembly repertoire of RAUMEDIC combines tubing and components into customised systems in sterile packaging.

Extrusion, injection moulding, assembly – all from one source!

RAUMEDIC assembles moulded parts with in-house extruded tubing via manual, semi- or fully-automated assembly.

Fully-automated assembly

Features and benefits

Æ Punching

Æ Printing

Æ Tip forming

Æ Thermoforming

Æ Microchip technology

Æ Integration of electronic components

Æ Packaging

Æ Sterilising

Æ Certifying

Fully-automated UV-curing

100% camera control

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Service worldwide! Let RAUMEDIC be your development partner!

Thanks to our global sales network we can service and advise our worldwide customers individually and locally.

RAUMEDIC AG

Hermann-Staudinger-Str. 2

95233 Helmbrechts

Germany

Tel.: + 49 (0) 92 52 359-0

Fax: + 49 (0) 92 52 359-1000 [email protected]

www.RAUMEDIC.com

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