After the Quality System has been established, you’re ready to start using it to finish documenting your Design History File and other company activities. The majority of these materials were started during the Precompliance portion of your journey, but now that your team has transitioned to full compliance by doing the above Compliance Transition Program, these activities will continue as you work towards the refinement and completion of your product for submission.
- Design and development planning
- Supplier qualification and quality agreement negotiation
- DHF records creation
- Validation and verification protocols generation
- Test lab management and oversight
- Manufacturing records creation
- Design transfer to manufacturing