Tools&Template
ISO 13485 template
The ISO 13485 is the standard for quality management in the medical device industry.Leave your contact information and we’ll be happy to help you with the following templates
- internal audit report
- PRRC Appointment letter;
- internal audit program
- SOP sales
- list of regulatory audit plan
- SOP Software Validation
ISO 14971 template
ISO 14971 is a risk management standard for medical device software.We publish all our document templates for the ISO 14971 for free：
- Risk management report;
- risk management plan and risk acceptance matirx
- FEMA