This includes external software as a service, e.g. You use a “ready”, that is, an already existing product within your product or medical device as the case may be. Component purchasing (“catalogue goods”).Here too, if this part or component is part of a medical device, it is to be considered a special case. ![]() ![]() You order the development of part of a product. A special case would be if this product is a medical device. You order the development of an entire product. Examples of products and services supplied externally are: Basic principles of supplier management a) Examples of suppliers and delivered products and servicesĪs soon as manufacturers stop developing something themselves and start buying it in, they require a supplier evaluation. ![]() It also gives you tips on how to implement them and tells you when a supplier audit is necessary. This article not only gives you an overview of the regulatory requirements. The MDR and ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection and supplier monitoring. Supplier evaluation – supplier selection – supplier audits
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