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Medical Device Process Validation Experts| The following experts are available as medical device process validation consultants and medical device process validation expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: Medical Device Process Validation -
Process validation for medical devices used in medical procedures. |
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| 1 to 25
(of 46) | | | Medical Device Process Validation Experts |
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Expert Quote | | |  | | Expert in Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product ... See full profile | | New Jersey (NJ), USA  | | | |  | | Expert in Internal Medicine, Critical Care Medicine, Medical Devices, ICU, Medical Informatics, Startups
Expert is a Pulmonary-Critical Care Medicine physician with experience directly providing patient care in the ICU setting. He has also been an Emergency Physician. Expert was Medical Director of the Medical ICU at The Methodist Hospital in Houston ... See full profile | | Texas (TX), USA | | | |  | | Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile | | Netherlands | | | |  | | Expert in FDA Medical Device Regulation, Expert Testimony
Expert initiately was a FDA field office investigator (drug manufacturing specialist) and compliance officer in the then FDA Bureau of Drugs. During his 17-year career in the FDA Center for Devices and Radiological Health Expert helped to initiate ... See full profile | | North Carolina (NC), USA | | | |  | | Expert in Medical Device Quick Prototyping/CAD Design/Concepting
Expert has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Manufacturing Automation, Statistical Process Control
Expert has more than thirty years of experience in the analysis of process and manufacturing data aimed at improving product quality and manufacturing process yield. While at DuPont he developed a technology to uncover latent ... See full profile | | Delaware (DE), USA | | | |  | | Expert in GMPs for Drugs, Devices, Biologics
The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Products Packaging: FDA Package Validation, Development Standards, Test Methods, ISO 11607
Expert has expertise in the field of medical device packaging for both single use disposable devices and for long-term implantable medical devices. His primary involvement has been in the design, development, and qualification of device ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement
Expert has an impressive and verifiable record of significant product, process and business improvements since 1980. These include: Time to market, new product development system improvement; Reengineering; Business unit performance and profitability ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile | | Oklahoma (OK), USA | | | |  | | Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile | | Minnesota (MN), USA | | | | | | Expert in Medical Device Sterilization
Expert is an expert in medical device sterilization. He has advanced technical knowledge in all phases of sterilization, including work with heat, chemical, and irradiation sterilization processes. He is especially adept with the irradiation ... See full profile | | South Carolina (SC), USA | | | |  | | Expert in FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile | | Pennsylvania (PA), USA | | | |  | | Expert in PRODUCT DESIGN AND MANUFACTURING (MEDICAL DEVICES, ELECTRONICS, OPTO-MECHANICAL)
For the last 20 years I was designing product and piecing up various parts using different material and process. My expertise in designing Plastics parts sheet metal and metal casting and working with supplier to deliver on time the parts and sustaining ... See full profile | | British Columbia, Canada | | | |  | | Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile | | Illinois (IL), USA | | | |  | | Expert in Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 20 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and ... See full profile | | California (CA), USA | | | |  | | Expert in Artificial Cardiac Pacemaker and Heart Failure
• r& d of Cardiac Resynchronization Management Devices (Cleveland Clinic Foundation) • Cardiac Resynchronization therapy (CRT) and related pacing paradigms (Cleveland Clinic) • Providing preoperative, operative, and postoperative physiological ... See full profile | | New York (NY), USA | | | |  | | Expert in Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device ... See full profile | | California (CA), USA | | | |  | | Expert in Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Biomedical Engineering and Patents, Biomedical & Electrical Device Designing, Eye Activity Devices
He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Completed coursework for Masters of Biomedical Engineering. Thesis being completed specializes in optics ... See full profile | | Tennessee (TN), USA | | | |  | | Expert in Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new ... See full profile | | Florida (FL), USA | | | |  | | Expert in Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance
Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. See full profile | | California (CA), USA | | | |  | | Expert in Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, ... See full profile | | Nevada (NV), USA | | |  | | >> Next 25 Experts
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