Risk assessment is one of the seven key elements of FDA’s QSIT. Our risk assessment methods are consistent with not only FDA but the requirements of ISO 14971.
Risk assessment has become an important tool in the design and manufacturing environment as well. DBT can assist the manufacturer in implementing this approach in reviewing and assessing the manufacturing process, CAPA, complaint evaluation to name a few.
- Determine rationales for verification or validation of the processes employed in the manufacture of your device.
- Reduction of risk
- DBT helps your engineering, manufacturing and quality systems groups:
- Understand the principals of risk assessment for medical devices at both the design and manufacturing stages.
- Develop risk assessment procedures including both FMEA and FTA models.
- Implement risk assessment as part of change control, validation or verification process activities or other areas related to the regulatory status of your product.
DBT’s technical skills coupled with its in-depth regulatory and quality systems experience separates DBT from other consulting organizations that offer either quality systems or technical consulting. Your company can depend on DBT’s multi-pronged approach in helping your organization with proven methods and approaches.