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Hello all,
i am new to the site but already found a lot of valuable information. my company develops a medical device that will be manufactured by an outsourcing manufacturer. does it mean that clause 7.5 "production and service provision" can be fully excluded from our QMS or we should still address some sub-clauses like validation, sterilization ect?
thanks.
i am new to the site but already found a lot of valuable information. my company develops a medical device that will be manufactured by an outsourcing manufacturer. does it mean that clause 7.5 "production and service provision" can be fully excluded from our QMS or we should still address some sub-clauses like validation, sterilization ect?
thanks.