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Iso 14971 pdf download4/28/2023 ![]() ![]() We describe below the steps BSI as a medical devices notified body plans to take to meet the requirements of EN ISO 14971:2012. EN ISO 14971:2012 applies only to manufacturers placing devices on the market in Europe for the rest of the world, ISO 14971:2007 remains the applicable standard. The 2012 version allows the presumption of conformity to the applicable Essential Requirements of the three Medical Device Directives, 90/385/EEC, 93/42/EEC and 98/79/EC. The 2009 version was considered obsolete as of the same date. On 31 July 2012 EN ISO 14971:2012, Medical devices - Application of risk management to medical devices, replaced EN ISO 14971:2009 as the European harmonised standard.
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