What records are needed for the entire production process of medical devices

If only refers to the production process, the records required are:

Contracts, production orders, contract evaluation records, procurement records, incoming material inspection records, warehousing records, production plans, material receiving records, production (daily) statements, the first piece of records, process inspection records, records of key parameters or special process parameters, records of environmental parameters in the process of production, the use of equipment in the process and maintenance records, relevant quality anomaly contact sheet (if any), warehousing orders, shipping inspection records, lot number comparison table, mold and tooling use or replacement records (if any), mold and tooling use or replacement records (if any), the use of medical devices or replacement records. Records, relevant quality abnormal contact list (if any), warehousing list, shipping inspection records, lot number comparison table, mold and fixture use or replacement records (and after the replacement of the verification confirmation records), shipping notification form, material replacement and return records.

The above constitutes a more complete DHR (also called batch record).

The above constitutes a more complete DHR (also called batch record).