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Richard already gave some good tips on how to handle such a situation. Leveling the weighing factor for poor quality upon delivery proportionate to the risk associated with the final device is certainly a valid option, in line with Clause 7.4.1 of ISO 13485. Another issue is the cost of non-quality. ...

Dear Anon, using the IMDRF ToC is a good approach. It however does not align with e.g. the eSTAR format used in the US nowadays. I advise to use the Design History File (or Design and development file, ISO 13485, clause 7.3.10) as the starting point. Such a file contains all design and development ...

Hi Noa, not neccessarily. Only when those documents need to be updated (e.g. because a design input requirements is changed, or an additional risk control measure is identified and added as design input requirement and consequently needing verification and validation). Your design change process ...

Hi Noah, Kimberly already gave good advice on the continuous update of risk management throughout the design and development cycle. I would like to add that in ISO 13485, Clause 7.3. is stated that, amongst others, applicable output of risk management is input for design. Of course not all risks ...

Hi Britta, the responsibilities of the obligations of an Importer cannot be delegated. In general, one cannot delegate a responsibility. It is possible to outsource certain activities related to the obligations of the IMP to the LH and having IMP a suitable level of 'supplier control' over those ...