medical research, medical affairs, pre-clinical research, pre-clinical models, pre-clinical trials, animal studies, experimental design, clinical research, clinical trials, clinical affairs, clinical strategy, clinical investigations, clinical operations, trial design, protocol design, investigator brochure, informed consent, investigator agreement, site contract, research design, clinical document authorship, site selection, international, world-wide, US, OUS, DSMB selection, CEC selection, trial management, personnel management, in-house staff, in-house personnel, field staff, field personnel, CRO, post-market trials, post-market research, regulated trials, unregulated trials, IDE trials, 510(k), budget planning, product development, product design, product evaluation, product enhancement, expand indications, product safety, product efficacy, scientific presentations, scientific publications, organizational ability, start-up experience, cardiovascular device, ablation device, implantable device, ablation catheter, pacemaker, defibrillator, Class III device, class 3 device, CE-mark trial, feasibility trial, pivotal trial, phase I, phase II, phase III, investigator selection, investigator training, budget negotiation, quality system, regulatory experience, vice president, signal processing, arrhythmia detection, electronic systems, real-time systems, data acquisition, ECG algorithm, drug-device combination, RF ablation, cryoablation, neurostimulation, spinal cord stimulation, chronic pain management, atrial fibrillation, atrial flutter, cardiac arrhythmia, off-pump CABG surgery, atrial defribillator, ventricular defibrillator, epicardial pacing, implantable drug pump, drug pump, Holter recorders, Holter monitoring, physiology, AHA arrhythmia database, medical advisor relations, engineering interface, cardiac electrophysiology, myocardial infarction, pathology, histology, marketing support go

Kenneth L. Ripley, M.S.E.E.

Consultant For:

  • Medical Device Design, Development and Evaluation
  • Pre-clinical Research and Experimental Models
  • Regulated and Unregulated Research / Clinical Trials
  • Clinical Trial Design, Implementation and Management
  • Clinical Trial Document Preparation
  • Specializing in Cardiovascular Devices
  • US IDE Trials and Filings
  • US 510(k) Filings
  • EU/OUS Trials
  • Post-Market Research
  • Personnel Management (In-house and Field)
  • Publications and Presentations
  • Interface to Medical Bodies and Advisors
  • Interface to FDA

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