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Risk Analysis Evaluation

Medical devices manufacturers, retailers and suppliers need to meet the regulatory compliance laws of each country or region for their devices, plus international and in some cases local standards.

The IEC 60601 Third Edition series requirements can be met with a risk analysis evaluation from SGS. This becomes mandatory in the EU and for Health Canada on June 1, 2012; and June 30, 2013 for the US FDA. Learn about the requirements and employ our medical devices expertise now in order to meet these critical deadlines.

It is never too early to involve a third party to conduct a risk analysis assessment. To ensure your compliance we conduct an assessment of the risk analysis carried out during your product development process. From the early concept stage of a device all the way to the initial production samples our worldwide network of affiliate labs can support you. We have the advantage of being well positioned globally in key countries such as China, Korea, and Brazil.

Find out how a review of your risk analysis and risk management file from SGS can help your business.

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Electro-Medical DevicesBrochureElectro-Medical Devices in Trusted HandsAs a medical devices manufacturer your focus is to create products that improve the quality of medical services provided around the world. However, ...
ROHS II ServicesLeafletSGS ROHS II Services for Medical DevicesEuropean Union Directive 2011/65/EU, also known as RoHS II (2011/65/EU) updates legislation governing the Restriction of Hazardous Substances in ...

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SGS North America Inc.
Consumer and Retail

  • Suwanee Laboratory
    620 Old Peachtree Road - SUITE 100
    Suwanee, Georgia, 30024
    United States
  • t   +1 770 570 1800
  • f   +1 770 277 1240
  • e   Email us

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