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Hello.
I am developing a QMS for biomedical start up company. We only do R&D, in that we will not be supplying a product or a service, merely licensing the technology for use in medical device companies (our technology is surface modification for orthopaedic devices). Our customers will handle all the validations and necessary approvals. Has anyone else in this forum experienced this type of scope for ISO 13485?
Thank you
I am developing a QMS for biomedical start up company. We only do R&D, in that we will not be supplying a product or a service, merely licensing the technology for use in medical device companies (our technology is surface modification for orthopaedic devices). Our customers will handle all the validations and necessary approvals. Has anyone else in this forum experienced this type of scope for ISO 13485?
Thank you