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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.

CT scanner

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.