Re: Anyone has experience in expanding its product range to medical industry?
New/revised SOPs shall cover,
1. compliance with regulations, such as QSR 21 CFR820, MDD etc (particularly design control, change control, SW validation, process validation)
2. complaint handling
3. assissing adverse event investigation if you are a parts supplier
4. allowing regulatory inspection, such FDA, a notified body etc.
5. document, records retention time complying with regulation
6. DMF, DHR, DHF, TF shall be established
7. 21CFR part 11 compliance if you have SW in your production, process control, quality records handling
8. (any more formthe cove?)