Product Lifecycle Management/DHF Consulting & Remediation
Product Lifecycle Management/DHF Consulting & Remediation
- Product Specification Development
- Verification and Validation Procedure Development
- Risk Analysis
- Fault Tree / FMECA Analysis
- Process Validation
- Product Design History File, Verification and Agency
- Testing Remediation
- Regulatory and Non Compliance Remediation
- Project Work Plan Development
- Consent decree remediation and product support
- Design changes to mitigate non-compliance issues
- Provide DHF documentation
- Gap Analysis, DHF and Agency compliance and mitigations
- Risk Analysis, Requirements, Test Protocols, Testing, Traceability
- 60601-1 Gap Analysis and remediation