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ISO 13485:2016 Certification for Design and Development

alt78

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Does anyone have any feedback on the minimum requirements for obtaining design and development ISO 13485:2016 certification at an initial phase 2 assessment? We have implemented sections 4, 5, 6 and 8 of ISO 13485 and are not adding manufacturing or distribution to the scope at this time. Is a design and development procedure and some evidence of implementation (e.g. early phase documents such as planning documents, early phase design reviews, design file information and some design verification) likely to satisfy requirements or would evidence of full implementation be required (i.e. through to design transfer)?
 
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