Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Quality Systems Consultant with Expertise in Vendor Evaluation, Process Improvements, Cost-Non-Quality for Investigations-Various Industries; Healthcare, Security Technologies, Medical Devices, Oil-Gas-Mining Fabrication, Grain Systems, and Specialty MetalsProcess audit specialist; product audit and Quality Management Systems (QMS).Lead 3rd party ISO Audit.Advanced Product Quality Planning (APQP), Production Part Approval Process, PPAP and National Provider Identifier, (NPI) management.Process improvement, value steam mapping and Lean Six Sigma.CAPA, (Corrective And Preventative Action) engineering studies, Statistical Process Control (SP...

Ph.D Scientist with Expertise in MRI Imaging, Pharmaceutical Biomarkers, In-Vivo Imaging and Medical Device ExpertSummaryDeveloping imaging biomarkers for the pharmaceutical and medical device industries.Biomedical imaging and computer sciences.Magnetic Resonance Imaging (MRI) data acquisition and data analysis, image and signal processing techniques, numerical methods, multicompartmental models and linear systems.Development and validation of quantitative imaging (MRI) biomarkers.Project management and study design of scientific (R&D) projects.Site training and implementation of in-vivo imaging studies.Quality control and analysis of imag...

Medical imaging, electronics, semi-conductors, medical devices, sensors, MEMS (Micro-Electro-Mechanical Systems), signal processing, image processing and ultrasound.Industrial and applications including, imaging, consumer electronics, biometric security, and electrical power delivery.Intellectual Property: Patent development, analysis, licensing, and strategy.Expert Witness ExperienceMedical malpractice (spinal injury, working with neurologist) - retained, filed initial statement with Court and deposition work.Product liability - wheelchair.Two patent infringement cases involving wearable consumer electronics.Trade secrets case involving...

Ph.D. Material Engineer with Expertise in Spun Molybdenum Crucibles, Sapphire Crystal Growth, and Tungsten Heavy Alloys for Penetrators, Radiation Shielding and Counter Weights for Medical Device and MilitaryAdvanced materials technologies.Produce radiation shielding and counter weights through the science in spun molybdenum crucibles for sapphire crystal growth and tungsten heavy alloys penetrators.Identify products to maximize potential marketing value in the plate, sheet, foil, rod, wire, and fabricated components for customers in multiple industries.Large-scale production of sapphire for watch faces and optical windows.Government cont...

Medical Device Marketing, Sales, Distribution, Business Development, Product Development Consultant: POCT, diagnostics, pediatrics, endoscopy, critical care, cardiovascular surgery, ENT/respiratory-care, IVD, MIS, IVUS, interventional-cardiology devices, and imaging.Point-Of-Care (POCT) diagnostics, pediatrics, endoscopy, critical care, cardiovascular surgery, ENT/respiratory-care, IVD, MIS, IVUS, interventional-cardiology devices, and imaging."Stage and gate process," product pricing strategies, branding, strategic partnerships and maximizing sales for profit and market share in new and mature markets.Business and engineering background o...

Innovative registered mechanical engineer for development and ISO9001 manufacture of medical cutting devices such as surgical quality tissue cutting edgesMedical device development and manufacturing implementation.Medical device and other product and process development including: Disposable and reusable medical device design, prototype and clinical supplies prototype fabrication and testing, manufacturing systems design and development, manufacturing tooling and fixture design, process piping, equipment installation and validation, sterilization and packaging validation.Product and manufacturing process improvement: Design of experiment...

Nutraceutical, Health Foods, Dietary Supplements and OTC Products Consultant. Custom Formulations for Dietary Supplements and OTC Products; Solid, Semisolid and Liquid Delivery. Sample Development, Research and Development, Raw Materials Sourcing and Specifications.Nutraceutical, Health Food, Pharmaceutical, and Medical Devices, new product development and research and discovery.Nutraceutical formulation development; Identifications and evaluation of new materials; process quality and improvement; quality system; and technical support.Dietary supplements and OTC product formulation.Ingredients sourcing for dietary supplements.Raw materia...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...