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Consider a medical device software company, after having a CE-mark certificate and ISO 13485.
If the company adds a new location for design and manufacture, while mantaining the legal mafacturer address (same existed in the original certificate) would they be required to re-issue the certificates to add the new location?
If the company adds a new location for design and manufacture, while mantaining the legal mafacturer address (same existed in the original certificate) would they be required to re-issue the certificates to add the new location?