VP QA RA Small Med Dev Company FDA and ISO13485:16
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?