Services offered by RESound

Medical Specialties

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Experience in the following fields:

  • Ablative therapies
  • Cancer diagnostics
  • Cardiovascular implants
  • Critical care
  • Electrophysiology
  • Hemodialysis
  • Neurosurgery
  • Orthopedics
  • Robotics
  • Structural heart
  • Wound care


Pre-Clinical

Pre-clinical consultant in medical device industry

  • Site identification and solicitation of competitive quotes
  • Protocol development
  • Management of Good Laboratory Practices (GLP) and non-GLP studies in the Study Director role
  • Compose study reports for future regulatory submissions

Clinical

Clinical  consultant in medical device industry

  • Author and review study protocols
  • Obtain regulatory and IRB approvals
  • Perform site training
  • Coordinate data management
  • Manage study sites 
  • Serve as principle liaison with CROs
  • Provide expertise in US and OUS studies
  • Develop economic analyses


Regulatory

Regulatory affairs medical device consultant

  • Author FDA pre-submissions
  • Prepare 510(k) and IDE submissions
  • Apply for Breakthrough Device designation
  • Apply for Humanitarian Device exemptions 
  • Represent clients at FDA meetings

Medical Writing

Medical writer for medical devices
Clinical Evaluation Reports
Clinical SOPs
clinical reports
public

  • Author and update Clinical Evaluation Reports (CERs)
  • Create clinical SOPs
  • Prepare clinical study reports
  • Author peer reviewed publications

Legal Affairs

Expert witness in medical device litigation

  • Serve as an Expert Witness in device litigation matters
  • Review and analyze trial documentation
  • Author Expert Witness reports
  • Testify in court proceedings