![]() Start at purchasing (and note that any raw materials you use must meet certain standards), all the way through to dispatch, installation and ongoing servicing, if that’s something your company does. Create a process flow: you must then produce a process flow.This is still classed as a medical device. Even if you don’t manufacture something commonly considered as a ‘device’, such as a scalpel or piece of medical equipment, you may manufacture a chemical that helps the device to function. Identify processes: firstly, it’s important to identify and collate all the processes your company carries out that are in any way connected with medical devices. ![]() There are of course nuances and further detail within each of these steps. This is a brief overview of the main things your company must do in order to achieve ISO 13485 certification.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |