Example:  See Closed Cases, Device Evaluation

• New or contemplated medical devices for:
  • Clinical user considerations
  • Associated user training
  • Risk assessment for equipment malfunction scenarios
  • User manuals
  • Device labeling
  • Marketing considerations
  • 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 with cooperating healthcare facilities and physicians.

• 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.

• Perform an 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.

• Work cooperatively with company designated staff to draft the 510(k) application.
• Coordinate product testing (if needed) to support the 510(k) application.
• Interface with FDA representatives regarding product questions.
• Interface with attorneys specialized in FDA 510(k) application procedures.