Conversely, ISO 9001 is not required to support medical device regulatory approval in any country. This standard is based on the internationally recognized ISO 9001 QMS standard (which is not specific to any industry or type of product) and incorporates additional elements relevant to medical device processes.Īlthough ISO 13485 only covers QMS requirements and does not define medical device quality, some countries require ISO 13485 certification to support medical device regulatory approval. ISO 13485 is a stand-alone standard published by the International Organization for Standardization (ISO) that provides requirements for quality management systems (QMS) of companies involved in the medical device industry.
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