Stereotaxis
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S-1/A
STEREOTAXIS, INC. filed this Form S-1/A on 05/12/2004
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1.6.2 DHR's will contain adequate information to identify the processing methods
      and personnel involved in the manufacture of a finished Product.

1.6.3 DHR's will contain adequate information to demonstrate that the
      manufactured Product was evaluated (tested and/or inspected) and found to
      meet the appropriate specifications.

1.7   Stereotaxis will establish written requirements, including specifications
      and drawings, for purchased materials and components and will implement a
      system to ensure that the materials and components supplied meet these
      specifications.

1.8   Stereotaxis will obtain agreements with suitable suppliers for all
      components, materials and services used in the manufacture of Products and
      that no changes in the goods or services supplied will be made without
      adequate notification to Stereotaxis.

1.9   Stereotaxis will have a system for assisting Biosense Webster with
      handling customer complaints.

1.9.1 All complaints involving Products supplied to Biosense Webster will be
      initially reported to Biosense Webster customer service. Stereotaxis will
      be promptly informed if the complaint involves a product supplied by
      Stereotaxis, and within seven (7) calendar days, provide a written
      preliminary investigation report to Biosense Webster Quality Assurance.
      This preliminary report will include an initial assessment of device
      reporting under MDR or Vigilance reporting requirements.

1.9.2 Stereotaxis will cooperate fully and promptly in the investigation of
      complaints involving supplied Products. All complaints should be
      investigated and a written response provided to Biosense Webster Quality
      Assurance within thirty (30) days of receipt. All correspondence with the
      complainant will be handled by Biosense Webster, unless other arrangements
      are made by Stereotaxis with Biosense Webster on a case-by-case basis.

1.9.3 Biosense Webster will be responsible for filing any device report under
      MDR or Vigilance reporting requirements.

1.9.4 In the event that corrective actions are warranted as the result of
      customer complaints for the supplied Products, these corrective actions
      will be incorporated and tracked as part of the Biosense Webster
      Corrective Action system.

1.10  If a problem that potentially affects the safety, efficacy or reliability
      of the Products is identified by either Stereotaxis or Biosense Webster,
      the problem and all known facts will be brought to the attention of both
      company's Quality Assurance management as soon as possible, but within 24
      hours of the identification of the problem. In the event that a field
      action is contemplated, Biosense Webster and Stereotaxis will work
      together to determine whether a field action should take place; however,
      the final decision to implement a field action will be made by the
      Biosense Webster Quality Management. Biosense Webster will be responsible
      for implementing any


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