If you need to remediate a DHF, let us help you! You can piece us in as needed or let us manage the project from start to finish. DHF remediation can have a major impact on your organization. Furthermore, if not completed properly the significant amount of rework that usually has to occur can have a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. We have remediated many DHF files for combination products and medical devices that have passed FDA and CE related inspections.
Deliverables we specialize in:
Design Controls
- Design and Development Plan
- User Needs and Stakeholder Needs
- Design Inputs
- Design Outputs
- Design Verification & Design Validation
- Test Method Validation
- Trace Matrix
Risk Management
- Risk Management Plan and Report
- Design Failure Mode Error Analysis (DFMEA)
- Process Failure Mode Error Analysis (PFMEA)
- Use Related Risk Analysis (URRA)
- Product Hazard Analysis (HA)
- Risk Analysis Matrix
- Clinical Risk Benefit Analysis (CRBA)
Design Transfer
- Creation of Device Master Record (DMR)
- IQ/OQ/PQ
- Process Validation
- Mold Approvals
