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medical device hazard analysis

  

analysis

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medical analysis

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case analysis

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Safe Medical Devices Act of 1990

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medical device coating material

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medical device corrosion

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medical software quality assurance

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medical device soldering

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Medical Device Reporting regulation

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medical device reporting

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medical device safety

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medical device testing

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medical device endotoxin detection

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medical device product development

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fault tree analysis

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risk assessment

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medical device

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failure modes and effects analysis

 

Medical Device Hazard Analysis Experts

The following experts are available as medical device hazard analysis consultants and medical device hazard analysis expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Medical Device Hazard Analysis - Analysis of a hazard associated with a medical device.

Experts Only

Join our distinguished experts for medical device hazard analysis jobs, projects and consulting opportunities.


1 to 25
(of 31)
Medical Device Hazard Analysis Experts
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Expert in Medical Product Design and Development
I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers and ... See full profile

California (CA), USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), 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 Electronics Design and Manufacture Reliability, Failure Analysis, Asia Manufacturer Risk Management
Expert has over 20 years of expanding responsibilities in the research and engineering of reliability risk identification, analysis, quantification and mitigation in the context of product and technology development. He is responsible for both technical ... See full profile

Washington (WA), USA

Expert in International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. See full profile

Wisconsin (WI), 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 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 Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs
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 Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. See full profile

California (CA), USA

Expert in Medical Device: Design, Development, Manufacturing and Quality Assurance
He has been involved in Good Manufacturing Practices (GMP) for over twenty seven years in Class II and III product environment. Set up and maintained Class 100,000 clean rooms and manufactured Class II Critical and Class III devices in this environment. See full profile

New York (NY), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in Reliability Engineering; Robot & Medical Device Reliability & Safety; Human Reliability
Expert has worked for a number of years in this industry. Over the years, he has developed many techniques and models to predict the reliability and safety of engineering systems including computers, mechanical equipment, robotic systems, ... See full profile

Ontario, Canada

Expert in Electrical and Biomedical Engineering, Patent Analysis, Medical Devices, Electrical Trauma
Expert is an expert in medical implants, devices and instrumentation; electrical and biomedical engineering; hospital x-ray and power systems; electrical power systems; electrical fire investigation; product safety and design deficiencies; ... See full profile

Illinois (IL), USA

Expert in Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... See full profile

Minnesota (MN), USA

Expert in Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the user. See full profile

Pennsylvania (PA), USA

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP
Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in all areas of general and specific management of a medical device ... See full profile

Minnesota (MN), USA

Expert in Medical Devices
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 Medical Device Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, ... See full profile

Minnesota (MN), USA

Expert in Electronic and Mechanical Device Reliability, Failure Analysis, Risk and Safety Assessment
Expert is an expert in the fields of reliability, risk, and safety assessment. He performs electronic and mechanical device reliability analysis, failure analysis, failure modes and effects analysis, and fault tree analysis. Expert is an expert in the fields ... See full profile

California (CA), 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 Business Development, Strategic Planning, Due Diligence, and Product Development
Expert has a doctorate in Biomedical Engineering and remains current with many of the advances in this field. He currently sits on the grant selection committee for the National Research Council of Canada. He has performed numerous consulting ... See full profile

Ontario, Canada

Expert in PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all ... See full profile

North Carolina (NC), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

Delaware (DE), USA

Expert in Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices ... See full profile

Ohio (OH), USA

Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc.
A nationally recognized expert in these areas, Expert has been dedicated to this field since 1986, when the FDA wrote their initial software guidance document. She has been responsible for compliance turn-around and start-up companies initial ... See full profile

Maryland (MD), USA

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