Batch production requirements

Vignesh M

Hi. we are a new startup of medical device manufacturing company. After completing the RND, currently we are planning to do batch production of our device. Batch production involves we will procure materials from vendors. two important vendors are there. one is printing 3D models for us. right now, they are gonna do vacuum casting and the second one is PCB membrane printing. We will do the assembly, QC, labeling, and packaging. right now, how we can standardize the process? Are there any specific requirements? our ultimate aim is to get ISO 13485 certification.


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You need to setup a procedure for purchasing and verification of purchased product (section 7.4 of ISO 13485).
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