Precision injection moulding

Extrusion

Moulding

Assembly

Precision

injection

moulding

Customised polymer

solutions

CERTIFICATE

The Certification Body of TÜV SÜD Management Service GmbH

certifies that

RAUMEDIC AG

Hermann-Staudinger Str. 2 95233 Helmbrechts, Germany including the sites and scope of app

lication see enclosure

has established and applies a Quality Management System. An audit was performed, Report No. 70101220 Proof has been furaccording to nished that the requirements

ISO 9001:2008

are fulfilled. The certificate is valid until 2013-04-30 Certificate Registration No. 12 100 257

75 TMS

Munich, 2010-06-04 Page 1 of 2

QMS-TGA-ZM-07-92

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

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

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

RAUMEDIC

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

know-ledge in these areas:

Æ Dehesive surfaces Æ Barrier functions Æ Antimicrobial properties Æ Anti-counterfeiting Æ Hygroscopic polymers Æ Alternative materials

RAUMEDIC

Design

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:

RAUMEDIC

Prototyping

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.

RAUMEDIC

Silicone moulding

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

RAUMEDIC develops and produces single and multi-

component solutions to highest demands.

Our silicone specialists develop customised product

solutions – from the initial idea to series production.

Catheter coupling for regional anesthetics

Luer cannula for eye surgery

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.

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

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.

RAUMEDIC

Insert- and Overmoulding

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

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

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.

Features and

benefits

RAUMEDIC

Assembly

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]