I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below:
1. Quality System Gap Assessment
2. CAPA
3. Form Cross Functional Team
4. Develop “Device Family” Bracketing Strategy
5. Update Policies and Create SOPs
6. Prepare Design and Development Plan and Define High Level Milestones
7. Create Design History File and Index
8. Create User-Needs Requirements Document
9. Compile and Conduct Risk Analyses
10. Prepare Design Input and Output Documents
11. Compile Historical Design Control Verifications
12. Verify Proper Design Transfer
13. Review Change Controls for Design Changes
14. Conduct Design Review/Verification Meetings per 820.30(e)
15. Conduct Risk-Based Remediation(s)
16. Prepare Design Verification Traceability Matrix
17. Final Plan and Close DHF
With respect to recreating the documentation, companies never work without any documentation. Whatever limited paperwork they may have should serve as basis for creating the DHF. “A compilation of documents/records necessary to demonstrate that the design was verified in accordance with the approved plan and specified requirements.”