Example:  See Closed Cases, FDA Consulting

• Medical Device as related to:
  • Inspector noted GMP (483) infractions
    • GMP infraction related to clinical user factors
    • Patient injury or adverse outcome risks
    • Independent product integrity testing
  • Clinical implications of product recalls
    • Alternate or substitute devices
    • "Doing without" scenarios
  • Risk assessment for equipment malfunction scenarios
  • User manual review
  • Device labeling review
• Product comparisons

• Medical device performance assessments using physiological simulators.
• Medical device performance assessments using environmental testing (heat, cold, humidity, EMI).
• Medical device performance using veterinarian supervised animal studies.
• Medical device clinical trials and/or testing evaluations for 510(k) or PMA applications.

• Working in cooperation with designated company staff, affected physicians, hospital biomedical staff, and regulatory agencies, perform independent investigation and confidential reporting for medical device related incidents or accidents.
• Assistance can be provided for proper reporting of the incident according to State and Federal requirements.
• Quality Control follow up procedures to address the causes of and future prevention of similar or related incidents.

• Independent confidential audit of designated complaint files to search out patterns of equipment reported problems.
• Recommend changes and/or actions to reduce medical device liability risks.  For example:
  • Targeted physician, nurse, or other healthcare professional training programs related to the subject technology.
  • Revision or upgrade of the targeted medical technology.
  • Enhanced biomedical support for the user facility.
  • Revised and upgraded manuals and device labeling.
• Confidential review of FDA 483 inspection reports for potential medical device liability issues.
• Independent assessment and assistance for voluntary and involuntary medical device warnings, "Dear Doctor" letters, and recalls.

• FDA designated review staff as needed for 510(k) medical device questions.
• Interface with FDA representatives regarding product comparison questions.
• Interface with attorneys specialized in FDA 510(k) application procedures for medical device related technical issues.