SGS Societe Generale de Surveillance : Electro Medical Device Services in Durham, United Kingdom
October 07, 2015 at 09:49 am EDT
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Introducing SGS DURHAM Lab
Established: 1992
Employees: 30
SGS's Durham lab was founded in1992 and. serves the following key competences for electro medical devices:
Product safety testing requirements of over 52 countries
US NRTL (UL standards) and standards council of Canada
Electromagnetic compatibility (EMC) testing
Wireless testing/telemedicine
Battery testing
Restricted substance testing, including testing to RoHS II requirements
Packaging testing consumer testing services
Laboratory features
Facilitating access to global markets, SGS UK is accredited by EU's certification schemes, as well as international bodies. This means we can provide technical support, pretesting, compliance testing, debugging, certification and production surveillance whatever the destination of our clients' products.
Dedicated test areas specific to Environmental
Mechanical & Performance Testing
Endurance Rooms
Metrology Testing
Anechoic Chambers
Medical, FFU, Material Testing
Radio, Shock and EMC Testing
Key Services
ISO 13485:2003
ISO 9001:2008 (for Medical Devices) in combination with ISO 13485:2003
93/42/EEC as amended by 2007/47/EC (Medical Devices DIrective, CE marking for the EU)
CMDCAS (Canadian Medical Devices Regulations)
510(k) support services for test data, advisory and factory follow-up
US Food and Drug Administration (FDA) site inspections
JPAL (japanese regulations for Medical Devices)
Other EC directives (CE marking of PPE, pressure vessels, NAWI)
Other regulatory certifications: including third-party certifications for Taiwan, Australia, Hong Kong and Brazil (INMETRO)
Other services related to Medical Devices include:
Biocompatibility and Biological Evaluation of Medical Devices according to ISO 10993
Audits - Supplier Audits, Gap Analysis Audits, Pharmaceutical and Cosmetic GMP Audits
Clinical trials
Hygienic qualification of production facilities
Microbiological Tests of products before and after sterilisation
Product Control for possible toxic residues from the sterilization process
Training including QMS/Auditing (ISO 13485:2003; Internal Auditing), Global Regulations (CE marking, FDA, JPAL), sterilization (radiation, ethylene oxide, steam), Risk Management (ISO 14971:2007), Product Safety and EMC (the IEC 60601 Series)
Quality marks
The SGS Durham lab offers a wide range of marks to help you gain access to the global marketplace:
USA NRTL (AAMI & UL Standards), SGS US/C certification mark
USA Test Reports as part of a FDA 510(k) or PMA, FCC
Canada (CSA Standards)
Europe (CE, EN Standards)
Brazil (INMETRO)
CB (Global, IEC Standards)
SGS Fimko, SGS CEBEC
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For further information, please contact:
SGS United Kingdom Limited
Unit 12A & 12B
Bowburn South Industrial Estate
Durham, Co Durham DH6 5AD
United Kingdom
t: +44 (0) 191 377 2000
www.sgs.co.uk
SGS SA is a Switzerland-based company that provides inspection, verification, testing and certification services. Inspection comprises checking the condition and weight of traded goods at transshipment, quality and quantity control, and compliance with regulatory requirements. Testing services are provided through a global network of testing facilities and test the quality, safety and performance of products against health, safety and regulatory standards. Certification services confirm if products, processes, systems or services are compliant with either national or international standards and regulations or customer defined standards. Verification focuses on ensuring that products and services comply with global standards and local regulations. Additionally, the Company offers training services through SGS Academy.
SGS SA 
