Representative of NB 1015

Contents

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IntroductionSZU - Engineering Test Institute

Competence Autorized Scop for Medical Device Technical InspectionCerti�cation of Management systemsCerti�cation of Products for ExportParticipation in National and International Organizations

SZU KOREA Medical Device Certi�cation Services Medical Device Regulatory Consulting Services

SZU Head O�ce - Engineering Test Institutewas established in 1898, January and place in Brno and branch in Jablonec nad Nisou is one of the largest accredited

testing and certifying bodies in the Czech Republic and is Authorized Body No. 202 and Noti�ed body No. 1015.

Czech Accreditation Institute accredited the SZU as testing laboratory, as certi�cation body for product certi�cation,

for certi�cation of quality management systems, for personal certi�cation, as well as inspection body and as calibra-

tion laboratory.

SZU is only one institute in the world which has UIAA accreditations for all mountaineering equipment and out�t

including helmets.

SZU KOREAis o�cial branch and representative of SZU – Engineering Test Institute, Noti�ed body No. 1015, in the scope

of testing and certi�cation of products in Korea.

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KOREA branch

RUSSIA branch

INDIA branch

ITALY branch CHINA branchTURKEY branch

CZECH REP Head Office

SZU - Engineering Test Institute

2000/14/EC 9/2002 Coll.

2006/95/EC 17/2003 Coll.

18/1997 Coll.

88/378/EEC 19/2003 Coll.

2009/105/EC 20/2003 Coll.

89/686/EEC 21/2003 Coll.

2009/142/EC 22/2003 Coll.

92/42/EEC 25/2003 Coll.

97/23/EC 26/2003 Coll.

95/16/EC 27/2003 Coll.

2010/35/EU 42/2003 Coll.

2000/9/EC 70/2002 Coll.

163/2002 Coll.

173/1997 Coll.

2006/42/EC 176/2008 Coll.

89/106/EEC 190/2002 Coll.

309/2005 Coll.

93/42/EEC 336/2004 Coll.

noise emission

low-voltage el. equipment

atomic act

toys

simple pressure vessels

personal protective equipment

gas appliances

e�ciency of hot water boilers

pressure equipment

lifts

transportable pressure equipment

drag lifts

selected building products

selected products

machinery

CE-marked construction products

nuclear facilities

medical devices

89/655/EEC 378/2001 Coll. safe operation and use of machines, technical equipment, instrumentsand tools

2004/108/EC 616/2006 Coll. EMC

The SZU - Engineering Test Institute, being EC Noti�ed Body 1015 and Authorized Body 202 is a wide spectrum of services in the

�elds and scopes of activities below in its basic premises in Brno and in the branch in Jablonec nad Nisou, based on its long-time

experience and competence based on ownership of the necessary accreditations, authorizations and noti�cations:

Competence

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MD 0100MD 0101MD 0102MD 0103

MD 0105MD 0106MD 0107

MD 0108MD 0200MD 0201MD 0202MD 0203

MD 0204MD 0301MD 0302MD 0303MD 0400MD 0401

MD 0402MD 0403MD 1100

MD 1101MD 1102MD 1103

MD 1104MD 1105MD 1106

MD 1107MD 1108MD 1109

MD 1111MD 1200

MD 1201MD 1202

MD 1300MD 1301MD 1302MD 1400MD 1401MD 1402MD 1403MD 1404

General non-active, non-implantable medical devicesNon-active devices for anaesthesia, emergency and intensive careNon-active devices for injection, infusion, transfusion and dialysisNon-active orthopaedic and rehabilitation devicesNon-active ophthalmologic devicesNon-active instrumentsContraceptive medical devicesNon-active medical devices for disinfecting, cleaning, rinsingNon-active implantsNon-active cardiovascular implantsNon-active orthopaedic implantsNon-active functional implantsNon-active soft tissue implantsBandages and wound dressingsSuture material and clampsOther medical devices for wound careNon-active dental devices and accessoriesNon-active dental equipment and instrumentsDental materialsDental implantsGeneral active medical devicesDevices for extra-corporal circulation, infusion and haemopheresisRespiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesiaDevices for stimulation or inhibitionActive surgical devicesActive ophthalmologic devicesActive dental devicesActive devices for disinfection and sterilisationActive rehabilitation devices and active prosthesesActive devices for patient positioning and transportSoftwareDevices for imagingImaging devices utilising ionizing radiationImaging devices utilising non-ionizing radiationMonitoring devicesMonitoring devices of non-vital physiological parametersMonitoring devices of vital physiological parametersDevices for radiation therapy and thermo therapyDevices utilising ionizing radiationDevices utilising non-ionizing radiationDevices for hyperthermia / hypothermiaDevices for (extracorporal) shock-wave therapy (lithotripsy)

MDS 7001MDS 7002MDS 7004MDS 7005MDS 7006

Medical devices incorporating medicinal substances, according to Directive 2001/83/EC Medical devices utilising tissues of animal origin, including Directive 2003/32/EC Medical devices referencing the Directive 2006/42/EC on machinery Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Medical devices in sterile condition

Authorized Scope for Medical Devices

Horizontal technical competence Limitations

Representative of NB 1015

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Technical Inspection

The SZU - Engineering Test Institute, being EC Noti�ed Body 1015 and Authorized Body 202 is ready to provide and grant a wide

spectrum of services. We o�er our services in the �eld covered by the Act No. 22/1997 Coll., as amended, on technical requirement

to products, concerning assessment of conformity and by related EC Directive (Government Regulations) as amended:

95/16/EC(27/2003 Coll.), lifts, 97/23/EC(26/2003 Coll.), pressure equipment, 2009/105/ES(20/2003 Coll.), simple pressure vessels,

2010/35/EU(42/2003 Coll.), transportable pressure equipment, 163/2002 Coll., selected construction products (welding consuma-

bles, reservoires and containers), 173/1997 Coll., devices for public entertainment incl. equipment of playgrounds, 2006/42/EC

(176/2008 Coll.), construction lifts and 309/2005 Coll., nuclear facilities.

Technical Inspection is accredited by the Czech Accreditation Institute as the Accredited Inspection Body No. 4008.

The inspection carries out assessment of conformity and certi�cation and provides tests and services in the �elds for which the

SZU - Engineering Test Institute is authorized and accredited :

TI - Technical Inspection also grants specialized technical services within the scope above in the process of assessment of conform-

ity as a third independent party, both for new and operated devices. All inspection activities can thus be utilized both by inland

manufacturers and importers or foreign vendors, whose activity is connected with the necessity to prove conformity when launch-

ing the Czech market or when exporting the products to EU countries.

The carried out inspection activity is always accompanied by a document in the form of the inspection report concerning result

of assessment of conformity with the speci�ed requirement for provision of safety of technical devices.

The Inspection Certi�cate, being the necessary precondition for issue of the "Declaration of Conformity" can be issued if all

requirements are ful�lled and met.

• pressure equipment

• hoisting devices incl. lifts

• electrical appliances

• gas appliances

• veri�cation of professional capability of the entities for speci�c activities

• technological units, including the equipment in areas with the danger of explosion of in�ammable gases, fumes and dust, and with the danger of �re or explosion of explosives

• devices for public entertainment, incl. equipment of playgrounds and installations with moving points of persons

• selected equipments specially designed for nuclear facilities

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Certi�cation of Management Systems

The Accredited Certi�cation Body for Management System Certi�cation No. 3007 accredited pursuant to ČSN

EN ISO/IEC 17021 by the Czech Accreditation Institute - signatory of the Multilateral Agreement of EA ("European co-operation for

Accreditation") o�ers the following to its customers:

Quality management system certi�cation pursuant to the standard ISO 9001:2008 in engineering companies and for selected services, ISO 13845:2003 for medical devices, EN ISO 3834-2:2005 for welding and OHSAS 18001:2007 for Occupational health and safety management systems.

The SZU - Engineering Test Institute is the member of the "CQS - Czech Association for Quality Certi�cation", associating further six

certi�cation organizations.

The "Association" is a full member in the IQNet (The International Certi�cation Network), consequently through SZU you can obtain

the certi�cate recognized in more than 30 countries (USA, Australia, EU, Israel, Japan, Canada, Korea, Switzerland, etc.).

Lead auditors of SZU are holders of QA and EOQ certi�cates.

In addition to it, they have long-time practice in management system veri�cation in companies with both, Czech and foreign

property participation.

Prices for management system certi�cation and audit are very favourable.

The same also concerns issue of the IQNet certi�cate.

Representative of NB 1015

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Certi�cation of Products for Export

The services o�ered in this �eld are mainly as follows:

• incoming analysis

• preparation of technical requirements

• product testing and check of documentation

• issue of certi�cates or reports

The Engineering Test Institute provides certi�cates particularly for the following territories:

Belarus, European Union, Russian Federation, Ukraine.

Furnishing the products by the relevant certi�cate and marking the products by the relevant certi�cation mark prior to launch-

ing the products is the necessity or at least business strength for a majority of foreign markets.

The Engineering Test Institute, being EC Noti�ed Body 1015, has gathered long-term experience in the �eld of overcoming the

technical obstacles to business and trading activities in foreign markets.

Based on the contacts and accreditations abroad, the Engineering Test Institute is able to provide a number of certi�cates facilitat-

ing launching of the products in the regions of interest.

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European committee for standardization

Safety commission of international mountaineering and climbing federation

Association of accredited and authorized organizations

International certi�cation network

International confederation of inspection and certi�cation organizations

Representative of NB 1015

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Participation in National and International Organizations

- Medical Device Registration in the Russian Federation

- Medical device GOST-R certi�cates in the Russian Federation

- Russian Sanitary-Epidemiological Conclusion (Hygiene Certi�cate)

- EC Certi�cation for Medical Devices, 93/42/EEC

- Certi�cation for ISO 13485, Management Quality System of Medical Devices

Medical Device Certi�cation Services

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1015

Representative of NB 1015

- FDA 510(k) Submissions for Obtaining FDA Approval (Clearance)

- FDA GMP Compliance Consulting

- US FDA Agent Representation for the Food & Drug Administration

- China SFDA Approval for Medical Devices

- Korean to Chinese Translation for Medical Device Companies

Medical Device Regulatory Consulting Services

Tel Fax031-995-6270 031-995-6279

www.szutest.cz www.szukorea.com

441-766 경기도 고양시 일산서구 대화동 1396 킨텍스 오피스빌딩 503

Representative of NB 1015