SGS introduces the comprehensive range of Electrical Medical Device services and certifications offered in its Atlanta medical devices laboratory.
Atlanta, GA, August 01, 2015 –(PR.com)– The SGS facility in Atlanta was opened in 2011 as another extension to the SGS Electrical and Electronic network of labs in the United States.
Today the lab serves the following key competences for electro medical devices:
– Product safety & Certification
– Electromagnetic compatibility (EMC)
– Wireless testing
– Battery testing
Medical Devices Laboratory Features
This lab serves as the gateway for electrical medical device services in the USA and Canada. The facility incorporates test and simulation labs covering an area of more than 28,000 square feet.
Accreditations and approvals received by this facility include:
– Notified Body for EMC and R&TTE Directives
– IECEE CB Scheme
– US OSHA NRTL
– Standards Council of Canada (SCC) testing & certification organization
– Field Inspection Body for onsite inspection of medical devices
Key Services for Electro Medical Devices
– EMC testing (http://www.sgs.com/en/Life-Sciences/Medical-Devices/Electrical-and-Electronics-Services/EMC-Testing.aspx) e.g. IEC EN 61326, IEC EN 60601-1-2 (10m chamber, 3m chamber)
– Product safety testing e.g. IEC EN 60601-x Series, IEC EN 61010-x Series
– Environmental simulation testing
– RoHS & WEEE
– Notified bodies (NB) CE 0120 & CE 0598
– Quality management systems (QMS) ISO 9001, ISO 13485
– Stability testing of packages and materials
The SGS technical team has experts in all electrical medical device testing services for complete products and accessories, such as surgical pencils and ECG leads.
Worldwide Certification and Quality Marks
The SGS Atlanta lab offers a wide range of regulatory and certification services cover the following requirements:
– USA NRTL (AAMI & UL Standards), SGS US/C Certification Mark
– EU: 93/42/EEC as amended by 2007/47/EC (Medical Devices Directive, CE Marking for Europe) & 98/79/EC (In Vitro Diagnostic Medical Device Directive, CE Marking for Europe)
– CMDCAS (Canadian Medical Devices Regulations)
– 510(k) Support services for test data, advisory, and factory follow-up U.S. Food & Drug Administration (FDA) Site Inspections
– JPAL (Japanese Regulations for Medical Devices)
– Global Regulatory Certifications, including third party certifications for Taiwan, Australia, Hong Kong and Brazil (INMETRO)
– CB scheme (http://www.sgs.com/en/Consumer-Goods-Retail/Medical-Devices/Audit-Certification-and-Verification/Regulatory-Certification/CB-Scheme.aspx) (Global, IEC Standards)
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.
SGS Consumer Testing Services
SGS North America Inc.
620 Old Peachtree Road
Suwanee, GA 30024