Hi All,
I am new here, I have a question for a company that do not produce medical device, but they supply Design & Automation line to the Medical device Manufacturer which is their customer. Practically, they do not need to be certified ISO13485, but the customer request them to be certified ISO13485 in order for them to sign a business contract.
Their business are in design and automation, where they will build the machines and software (manufacturing line) for the customer. Test run the manufacturing line and then transfer the whole line to customer's premise.
Hence, I would like to enquire what are the exclusions can the company apply since they do not have any medical device products manufacture in their premise?
I am new here, I have a question for a company that do not produce medical device, but they supply Design & Automation line to the Medical device Manufacturer which is their customer. Practically, they do not need to be certified ISO13485, but the customer request them to be certified ISO13485 in order for them to sign a business contract.
Their business are in design and automation, where they will build the machines and software (manufacturing line) for the customer. Test run the manufacturing line and then transfer the whole line to customer's premise.
Hence, I would like to enquire what are the exclusions can the company apply since they do not have any medical device products manufacture in their premise?