- Gap Analysis
- Complaint History
- Upgrade risk management to ISO 14971-2012
- Label and UDI conformance
- Upgrade test methods
- Upgrade performance specifications
- Design Verification Testing (if required)
- Human Factors Evaluation (or rationale)
Hire Us for a Three Day Gap Analysis
- Review legacy product documents to current company standard operating procedures
- Would you submit these documents today for a new product?
- Are risk management documents current to ISO 14971-2012?
- Is labeling current? Are you UDI compliant?
- Is legacy testing current to current standards (e.g. biocompatibility, IEC 60601, ROHS)
- Can an auditor find documentation to prove you meet your indication for use, safety and marketing claims?
- Do you need clinical data to show efficacy?
Risk management rules have changed. Are your risk management files still current?
- How do you asses the severity of harm, probability of a hazardous situation leading to harm?
- We have employed clinicians to help answer these questions and can help you do the same.
- Physician estimates of harm and probability are more credible than a room of engineers and marketers
- Have you reviewed your complaint history since the legacy product was launched?
- Has your risk document been updated based on complaint history?