SGS Offering Global Compliance Testing and Safety Services For Medical Products
SGS, a leading company for testing, inspection, and certification for medical products, supports the Electrical and Electronics industry with various solutions to meet their requirements. Through its global network of local teams, SGS can ensure expertise in the fields of regulation and compliance, safety, performance, EMC and chemistry, energy efficiency, and sustainability for electrical and electronic products.
Compliance testing and certification, software life cycle processes evaluation and IEC 61508 evaluations are just some of SGS’s functional safety services in relation to international standards for medical devices. Electronic medical devices and systems are used in almost every environment where patients receive medical services – operating theatres, doctors’ surgeries, physiotherapy centers, ambulances, and even in the home. To ensure accuracy and consistency manufacturers need to design products that mitigate the risk of human error, poor usability, or technical errors.
For the European markets, Medical device manufacturers must demonstrate that products, software, and hardware, comply with Medical Devices Directive 93/42/EEC (MDD), and the US market is regulated by the US Food and Drug Administration (US FDA). National or local authorities address different requirements for medical devices.
SGS provides a toolbox of solutions that enables the companies to achieve compliance with all relevant requirements for active medical devices.
Services offered by SGC to ensure that medical products are Compliant:
- Compliance testing and certification according to IEC/EN 60601/80601 standard including general safety, EMC, usability, alarm systems, home healthcare and emergency medical services.
- Medical device software life cycle processes evaluation (IEC 62304).
- Evaluation of compliance with IEC 61508.
Additionally, SGC also provides Compliance services to medical software applications (or ‘apps’) with the CE Conformity Declaration, in accordance with medical products regulations. The experts at SGC provide:
- Training on procedures and requirements of the CE Declaration of Annex VII.
- Clarification of the applicable medical device standards.
- Examination of the documents to be submitted.
These key services that are provided by SGC ensure that customers benefit from customized plans to resolve multiple challenges, including enhanced product performance, improved product quality, reduced failure rates, and increased customer experience.
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