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Medical Software Quality Assurance Experts

The following experts are available as medical software quality assurance consultants and medical software quality assurance expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Medical Software Quality Assurance - The process of quality assurance applied to medical software.

Synonyms:  medical software QA

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Join our distinguished experts for medical software quality assurance jobs, projects and consulting opportunities.


1 to 23
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Medical Software Quality Assurance Experts
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Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Software - Quality Assurance, Regulatory Affairs and Licensing
Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA ... See full profile

United Kingdom

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 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 Intellectual Property Transactions,Technology Transfer, Licensing, Software, Medical Devices
Expert is a C-level Business Executive with expertise in high-value/risk intellectual property (IP) transactions; technology transfer and licensing; medical devices and related technologies, software and hardware engineering development. See full profile

Massachusetts (MA), USA

Expert in Medical Device Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several ... See full profile

New Jersey (NJ), USA

Expert in Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and ... See full profile

Minnesota (MN), 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 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

Expert in Software Process Standards
Expert is considered an expert on the standards required to write software for the Web. He recently co-authored the book: A Guide to Standards and Specifications for Designing Web Software (Artech House, 1998). He has published three books on software ... See full profile

Washington (WA), 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 Biomedical Engineering, Patents, Medical Device Design, Product Development, 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. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye ... See full profile

Tennessee (TN), USA

Expert in Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and has been ... See full profile

Massachusetts (MA), 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 Software Engineer, Testing, QA
Computer software engineering; software development tool; software testing. Expert is Chairman and CEO of Expert's Firm (SR) of San Francisco, California. He is a leading figure in the software engineering community, specializing in ... See full profile

California (CA), 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 Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare ... See full profile

Illinois (IL), 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 AOI Industrial Inspection: Processes, Feasibility, Optimization; AOI Equipment: Design / Upgrades
Expert founded a consulting company specializing in supporting the manufacturing industry, which uses AOI, automated optical inspection or measurement systems in their production processes. Her emphasis is on practical support for the manufacturing ... See full profile

Limerick, Ireland

Expert in Hearing and Speech Science, and Audio Signal Processing
Expert offers comprehensive expertise in audio signal processing, including speech, audio, and music. His role can cover basic research, conceptual development, project management, feasibility studies, literature searches, experiment design, and product ... See full profile

Massachusetts (MA), USA

Expert in Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease) published in 1995. He developed an asthma clinical guidance system, developed three ... See full profile

California (CA), USA

Expert in Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of ... See full profile

New York (NY), USA

Expert in Software Engineering, Testing, Integration, SQA, Real Time Systems, etc.
Expert is the principal author of DOD-STD-2167, Defense System Software Development, and served on the executive committees for many other software management standards (DOD-STD-2167A; DOD-STD-2168; MIL-STD-498; EIA/IEEE J-STD-016; IEEE/EIA ... See full profile

Massachusetts (MA), USA

 
 

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