1. Medical devices
Contact
SLG Prüf- und Zertifizierungs GmbH
Burgstädter Straße 20
09232 Hartmannsdorf
Germany
Do you have any questions? We will be pleased to advise you:
Phone: +49 (0) 3722 73 23 792
Fax: +49 (0) 3722 73 23 899
E-mail: med@slg.de.com
Website: www.slg.de.com
Our Asian branch offices:
SLG Technology Service Shanghai Co., Ltd.
SLG Technology Service Hong Kong Co., Ltd.
SLG Asia Test Labs & Service (HK) Ltd.
SLG-CPC Testlaboratory Co., Ltd., Dongguan
Education and training
The X-ray Ordinance requires that expert knowledge in radiation
protection is to be acquired in specific training courses and
updated on a regular basis.
We conduct acknowledged radiation protection training courses
according to the “Fachkunderichtlinie Technik” of the X-ray
Ordinance.
For the medical devices sector, this applies to the following
fields of occupation:
 Testing, trial, maintenance and repair of x-ray diagnosis
equipment subject to quality assurance according to
§§ 16/17 of the X-ray Ordinance
(“Fachkundegruppe” R6.1 and R6.2)
 Assuming of tasks or employment of personnel in
connection with the operation of external x-ray diagnosis
equipment or external parasitic x-ray emitters
 Qualified experts according to the X-ray Ordinance
SLG-Medicaldevices-01
Please, visit our website at www.slg.de.com for more
information on our services.

2. Test laboratory for medical devices
Producers of medical devices face increasing challenges. In-
novation and progress govern the market while at the same time,
legal regulations tighten.
Product liability is a sensitive topic in the medical devices
sector. We support producers in ensuring compliance with legal
stipulations by providing all testing services and certifications
required for placing their products on the market.
 Safety and function tests
 Evaluation of handling / fitness for use
 Standard research
 Product classification and metrological verification
 Risk analysis
 Assessment of medical software
In addition, we offer trainings on safety aspects, radiation
protection and laser safety.
Certification body for QM systems
SLG is a neutral and independent certification body specialized
on the certification of QM/ QA systems. We check whether your
QM/ QA system complies with the applicable directives and stan-
dards and if positive, issue a corresponding certificate.
Benefit from the certification of your QM/ QA system by:
 Enhancing your chances on national and international
markets
 Winning customer confidence
 Verifying the efficiency of your company’s operational
procedures
 Minimizing your risks concerning product liability
 Proving compliance with the legal requirements
We certify your QM/ QA system in accordance with:
 Medical Device Directive
 DIN EN ISO 9001
 DIN EN ISO 13485
Radiation protection concerning x-ray
diagnosis equipment
Radiation protection both comprises the safe operation of equip-
ment and the protection of man and the environment from adverse
effects of ionizing and non-ionizing radiation.
The German X-ray Ordinance (RöV) and Radiation Protection
Ordinance (StrlSchV) establish requirements for the application
of ionizing radiation with the aim of protecting the general public,
medical personnel and patients.
We support you in the fields of radiation protection and applica-
tion of ionizing radiation for medical purposes and in technology
regarding:
 Compliance with legal requirements
 Radiation protection measurements
 Organization of radiation protection
 Planning of radiation protection for buildings
 Safety and EMC tests
SLG – Notified Body CE 0494 and accredited test laboratory
for medical devices