• Marketing and claims assessment
• Biocompatibility Risk Assessment
• ISO 10993 Parts 1-20 Device Biological Safety
• Consultancy and CRO Capabilities
• Regulatory Stategies n Submissions
• Clinical Evaluations for the EU
• Protocol Design, Study Design
• IVD Study Designs
• Sample Size Calculations
• Project Management for Clinical Studies
• Regulation of Human Investigations
• Monitoring
• Data Monitoring Boards
• Data Management, Database Design
• Statistical Analysis
• Final Reports, Manuscripts
• 510(k) Submisstions
• Site and Sponsor Audits
• Design Control Audits
• ISO 13485 Quality Mgmt Systems for Clinical Investigations
• ISO 14155 (Device Good Clinical Practice) Compliance
• ISO 14971 Risk Managerment (for Clinical Trials

• Collagen implants
• Cardiovascular stents
• Cardiac re-synchronization
• Membrane oxygenation
• Arterial perfusion
• Deep brain stimulation
• Heart-lung machines, perfusion
• Wireless PDA operating systems
• Monoclonal antibody assays
• Direct-labeled probe assays
• ThinPrep Pap smear imaging
• Drug delivery devices
• Interventional cardiology
• Dental devices
• Bone growth stimulation, replacement
• External fixation devices
• Interventional cardiology
• Spinal implants
• Soft-tissue implants
• Imaging
• Lasers, YAG, Excimer, Cold
• Personal products

• Judi Bednarz—market research
• Dan McLain—toxicology
• Charles Hurwitz—medical writing
• Brian Hartman—information specialist
• Sunny Worel—information specialist
• Kathleen Johnson—regulatory expert
• Kathy Selover—regulatory expert
• Michelle Secic—biostatistician
• Robert Thiel—IVD & Bayesian statistics

• Lynette Chiapperino—monitor, clinical project manager
• Sue Lesly—clinical study implementation
• Steven Schurr—data monitoring committee management
• Wessam Sonbol—database design
• Todd Colbeth—data management
• Vincent Jaeger—reimbursement specialist