Questions about the implementation

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.

ISO 13485 must be implemented and certified before manufacturing starts and before you put a medical device on the market. You have to prepare your quality management system like you can start the production right now. Of course, you can have some pilots production conducted, due to perform validations of certain processes, like cleaning and sterilization.

2. Is English as language enough or is the country language additionally necessary?

Given that notifying bodies reviewing the quality system according to ISO 13485 are internationally recognized, that they have offices in different countries, English is sufficient.

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).

Our ISO 13485:2016 documentation toolkit is prepared for all small manufacturers of medical devices. Since In vitro diagnostic products are also medical devices, our ISO 13485:2016 toolkit is applicable for in vitro diagnostic product manufacturers.