I am *** from medical device (glove manufacturer) company. As the pic for the design & development , would like to get more understanding regarding design & development as per 1S0 13485 (also MDSAP if can). There are few question from me which hope you can advise:
1) We are OEM company, so one product will be sell to few customers.
a) the market region might be differ according to customers. So how should I put into the design input as it also covers the markets region. Example, the product is design to customer A for US market. After few years customer B would like to purchase the same product but for Australia market. Should we just revised the design input or need to remark into design changes? Need your comment.
2. Can you elaborate further for IS0 13485 clause 7.3.3 Design Inputs which stated " Requirement shall be complete, unambigous, able to be verified or validated, and not conflict to each other" ? How can we verify these ?
Looking forward to your reply. Thanks.