It's our commitment to ensuring the safety and compliance of medical devices and materials. With meticulous monitoring, reporting, and analysis, we safeguard the well-being of patients and uphold the highest standards in healthcare product safety.
- Complaint Intake
- Complaint Management with QMS tools
- Complaint Investigation
Complaint
- Reporting
- Complaint Closure
- Benefit-risk determination
- Updating design, manufacturing info, instructions, and labeling, etc.
- Post Market Clinical Follow-up Plan and Report
- Identify device needs for preventive, corrective, or field safety actions
- NC Investigation
- Root Cause Analysis
- Corrective Action Plan
- Preventive Action Plan
- CAPA Implementation
- CAPA Effectiveness
- NC Closure
- Literature Search and Review
- Response To Questions (RTQs)
- Clinical documents such as Protocols
- Complete end-to-end Clinical
- Evaluation Report /Clinical Evaluation
- Planning Writing and Consultation
- Vigilance Report Submissions
- Field Safety Corrective Actions
- Field Safety Notice
- SAP, TrackWise, SmartSolve, and Arena
It is essential to collect all the necessary information to perform an adequate evaluation of the reportability of the event.
In another article, we have discussed the techniques for root-cause analysis. In the context of complaint handling, technical investigation can be quite different depending on the type of events and type of potential failures. However, in general, technical investigation may contain the following items:
Once the root-cause of the event is determined, it is important that a risk assessment is performed to ensure the risk is considered acceptable. Unacceptable risks for a marketed medical device necessitate field safety corrective action or field safety notice to be implemented.
Response to customers with a summary of the complaint received and the results of the investigation shall be provided under the following situations:
Research – including:
Requisite MDR PMS Revisions: