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Ce rtifi cate BEl 21 22357 4493. 00

The management system of

Materialise N.V.
Technologielaan 15
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3001 Leuven, Belgium
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has been assessed and certif¡ed as meet¡ng the requirements of k,
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ISO 13485:2003
EN ISO 13485:2012
For the following activities

The scope of registration appears on page 2 of this certificate.

This certificate is valid from 24February 2017 until3l March 2019


and remains valid subject to satisfactory surveillance audits.
Re certification audit due before 31 March 2019
lssue 7. Certified since 06 March2012

Multiple certificates have been issued for this scope


The main certificate is numbered 88121223574493.00

This is a multi-site certification.


Additional site details are listed on the subsequent page.

Authorised by

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U KAS
MANACEMENT
SYSTEMS
SGS United Kingdom Ltd
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK
0005
t +44 (0)151 350-6666 f +44 (0)151 350-6600 www.sgs.com

scs 1 3485-2 0614 M2

Page 1 of 2

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This dæurent ¡s i$ued by lhe Company subjectto its GeneralConditions of


Cêrtjf €tjon S€ryi6 ææible at ww.sgs.com,{erm_and_@nditions.hlm.
Attention is drawn to hs limilâüons of l¡abilìty, Indomnif€lion and jurisdictionat
issuæ ætablisM ttsreìn. The aulhfilic¡ty of lhis dæumnt my b€ veriM at
hþ:/itw.sgs.ænbn/ærtif od{liônb-ard-prodwb/ærtilî€d{lisnt{ietory.
Any umuüìorizod alloralion, forgery q faþ ifi€tion of üp @0lent q appeatrn6
of b¡s d@rent is unlefuland olendoß may be pf@ulsd to hs tullst
extent of ho |il.
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Certificate 8812122357 4493.00, continued

Materialise N.V,

U'
ISO 13485:2003 o
EN ISO 13485:2012 sG$
lssue 7

Detailed scope

Design, development, manufacture and distribution of:


. medical image processing, simulation and design software,
. custom made medical models,
. non-sterile custom made surgical implants and implant solutions
. non-sterile custom made surgical guides
. non-sterile cranio-maxillofacial metal implants
for the area of orthopaedic and cranio.maxillofacial surgery
and biomedical engineering and research

Additional facilities

Materialise Ukraine, LLC


Raisy Okypnoi 84, 02002 Kyiv, Ukraine

Materialise USA, LLC


44650 Helm Ct, Plymouth, Michigan , United States

Materialise Sdn Bhd


Unit 5-01, Menara OBYU, No.4, Jalan PJU 8/84, Damansara Perdana
47820 Petaling Jaya, Selangor, Malaysia
U KAS
P
MANACEMENT
Materialise Colombia S.A.S. SYSTEMS
Galle 29, Building nr 41 105 Office nr 401, Edificio S.O.H.O., Medellin, Golombia
0005
Materialise Japan K.K. Advanced Manufacturing
Mori First Bldg. lF,2-593 Saiwai-cho, Saiwai.ku, Kawasaki,212-0011
Kanagawa, Japan

Materialise OBL France


70-86 Avenue de la République, lmmeuble Vecteur BâtimentA ,, . ,,.,:.'.,

:92320 l. :,..: ,i:,


, France :.. '.l
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ïh¡s dæumont¡s ¡ssued by th€ C¡mpany subjællo its Genoral Cond¡üons of ,r ''i ::'l
Certiiæ$on S€ry¡6 æ$ible at ww.sgs.æmioms_and-@nd¡lions.hln. ' i'ì1.''
Attêntion ¡s dr4n to lhs limitat¡ons of liabil¡ty, iûdemnif€lion and jurisdicüonal Page2ol2
issuæ establ¡shed thoro¡n. Thê aulhenlicity ofù¡s dæument may be verifed at
htþ:/l¡¿w.sgs.@ûton/ærtified{lisnts-and,products/certäed-client-dirælqy.
Any unaul¡odzed alloration, forg€ry or lalsif€tion of th€ @nt€nt or appæranæ
of lh¡s dæurent is unlawfuland oñendeß may be pMuted lo ligfullost
exlenl ôflho lãw

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