SGS Offers Electrical Medical Device Services in Durham, United Kingdom

Durham, United Kingdom, January 06, 2016 --(PR.com)-- SGS’ Durham lab was founded in 1992. It employs 30 staff members and serves the following key competences for electrical 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

SGS Durham Laboratory Features

Facilitating access to global markets, SGS UK is accredited by EU’s certification schemes, as well as international bodies. This means SGS can provide technical support, pretesting, compliance testing, debugging, certification and production surveillance whatever the destination of 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

Principal 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 sterilization
- 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)

The SGS Durham lab offers a wide range of regulatory and certification services (http://www.sgs.com/en/Consumer-Goods-Retail/Medical-Devices/Electrical-and-Electronics-Services.aspx).

For more information, please contact an SGS expert or representative.

LinkedIn: www.linkedin.com/company/sgs-life-sciences

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.