The edition of „ISO 13485:2016 Medical devices. A practical guide” provides users with practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. It contains guidance applicable to various stages of the medical product’s life cycle and is aimed to all organizations, regardless of size and the nature of their business, it helps create a level playing field and facilitate the market access of their products globally.
The edition is available in pdf format online and on CD in English. The customers who have purchased BDS EN ISO 13485:2016 enjoy a 10 % discount on the price of the handbook.
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