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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
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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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