QA RA Small Med Dev Company
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Working as QA RA lead on a project bringing our prod in house (ISO 13485 FDA Class II) from a contract manu. The lead engineer is insisting I determine what the requirements are for the machines and tool and the environment we use. I am stating that aside from ISO 14121 there are none. The requirements are the tools are safe/effective have been through V&V. The environment is not prescribed and just states we have to determine the env controls and implement and monitor them. Is this correct?