Trusted globally, SGS’s electro medical devices testing services help you to find the fastest and most reliable route to market.
In the electro-medical devices sector, trusted suppliers and partners are key to reaching your target markets. We have the specialized industry knowledge and market experience to help you stay on top of regulatory requirements around the world. With our customizable test and audit packages, you can ensure compliance with the requirements of multiple target markets at the same time.
Our electro-medical service portfolio includes:
For all EU and International Product Safety Regulations, US NRTL, Standard council of Canada, EMC (IEC/EN 60601-1-2, and IEC/EN 61326 series including CB), functional safety, wireless devices, rechargeable batteries, restricted substances, packaging and the product safety of medical diagnostic x-ray devices.
During the product development phase with screening of risk management, software life cycle and usability activities.
Against all relevant ISO standards – 13485, 9001 and 14001, the major EU Medical Directives – 93/42/EEC and 98/79/EC, as well as other EC directives, US 510(k) Support Services, US FDA Site Inspections, JPAL and others.
For medical device regulations, standards and testing practices.
Like biocompatibility evaluation, audits, clinical trials, hygienic qualification, microbiological tests of products, product control for possible toxic residues and failure analysis for root cause clarification of malfunction on all kind of active and passive medical devices.
Our global network of experts and testing labs allows you to access the entire range of trusted SGS services in your manufacturing region and close to all major medical markets, at all times.
Regardless of the project size and number of markets targeted, we can improve the efficiency and value of your operation by combining the advantages of our worldwide reach, the wide range of accreditations, resources and global expertise into one global package.
An SGS Electro-Medical service package specifically customized to your needs is just a few clicks away.
620 Old Peachtree Road NW, Ste. 100,
Suwanee, Georgia, GA 30024,