1. When the ISO needs to be finished / audited? (e.g. when company is founded, when first device is sold or…? – E.g. Section 7: Product Realization is with planning etc. is running right now while the company is not yet founded.
2. Is English as language enough or is the country language additionally necessary?
3. Is the IVD guideline 98/79/EG (IVDD) and/or German “In-vitro-Diagnostika-Verordnung (IVDR)“ additionally necessary and incorporated in your toolkit? If not, can you recommend a toolkit for this? Background: In simple terms, the product is a special microscope with which a view of a tissue sample can be created and viewed. The interpretation of this image is done by a pathologist (unlike, for example, a blood pressure monitor, where the device interprets something). Staining of the tissue sample is done outside the device using standard procedures/products from appropriate manufacturers (e.g. H&E staining).