Capabilities Sampler
Technology Sampler
• Marketing and claims assessment
• Biocompatibility Safety Assessment
• Device Biological Safety Reports (Movie)
• Consultancy and CRO Capabilities
• Regulatory Strategies 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) Submissions
• 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 Management (for Clinical Trials
• Biocompatibility Safety Assessment
• Device Biological Safety Reports (Movie)
• Consultancy and CRO Capabilities
• Regulatory Strategies 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) Submissions
• 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 Management (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
• 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
Men's New Orleans Saints Nike Black Kick Off Staff Performance Pullover Hoodie,Detroit Lions 23" Mission Tiffany Table Lamp Cheap Jacksonville Jaguars Blake Bortles Jersey The Jacksonville Jaguars Jerseys For Sale .Men's New York Jets Green 2015 On-Field 39THIRTY Flex Hat,New Era San Diego Chargers Gradation 39THIRTY Flex Hat - Powder Blue/Navy Blue Blake Bortles Jersey Sale Jacksonville Jaguars Jerseys Cheap
Network Staff Associates
• Judi Bednarz—market research
• Dan McLain—toxicology
• Bert Albers—cardiovascular regulations & investigations
• Charles Hurwitz—clinical evaluations & other medical writing
• Tim Brown—spine & orthopedics regulations & clinical evaluations
• Brian Hartman—information specialist
• Sunny Worel—information specialist
• Kathleen Johnson—regulatory expert
• Kathy Selover—regulatory expert
• Michelle Secic—biostatistician
• Robert Thiel—IVD & Bayesian statistics
• Dan McLain—toxicology
• Bert Albers—cardiovascular regulations & investigations
• Charles Hurwitz—clinical evaluations & other medical writing
• Tim Brown—spine & orthopedics regulations & clinical evaluations
• 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
• Denise Baker—clinical evaluations & device quality systems
• Sue Lesly—clinical study implementation
• Patricia Hamilton—Latin & South American regulations & investigations
• Steven Schurr—data monitoring committee management
• Wessam Sonbol—database design
• Todd Colbeth—data management
• Vincent Jaeger—reimbursement specialist
• Denise Baker—clinical evaluations & device quality systems
• Sue Lesly—clinical study implementation
• Patricia Hamilton—Latin & South American regulations & investigations
• Steven Schurr—data monitoring committee management
• Wessam Sonbol—database design
• Todd Colbeth—data management
• Vincent Jaeger—reimbursement specialist
