Our DHF Remediation Process

  • 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

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

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?

Create a clinician based hazard analysis; cut your analysis time by 70%

Design Verification

  • How did they set their specifications way back then?
  • Does the data support your sample sizes for risk management now
  • Do you know how they tested this device 20 years ago?
  • What test methods were used? Are they documented?
  • Does your document support your shelf life claims?
  • Have standards changed? Is your testing current?

Could an auditor poke holes in your legacy test data?

Labeling

  • Are your labels UDI complaint?
  • Do your label graphics need an update?
  • Are language translations adequate for legacy products?
  • Do you have the internal resources to fix your labels and IFU's?

Offshoring labeling graphic design is a good solution

Hire Us for a Three days Gap Analysis