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Experts in Medical Device Manufacturing Quality Control

The following experts are available as medical device manufacturing quality control consultants and medical device manufacturing quality control expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Medical Device Manufacturing Quality Control - Quality control applied to manufactured medical devices.

Synonyms:  medical device manufacturing QC, medical device production QC, medical device production quality control

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Experts in Medical Device Manufacturing Quality Control
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Expert in Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(k)s for more than 25 IVD (In Vitro Diagnostics) products. These 510(k)s encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. See full profile

California (CA), USA

Expert in Home Health Care, Home Infusion Therapy, Hospice, Molecular Diagnostics, Personal Assistance Service
Expert is a highly accomplished Healthcare Senior Sales Executive with thirty plus years of experience founding, funding, developing and helping others develop Emergent Health Care Companies, building territories and leading teams to achieve and ... See full profile

Texas (TX), USA

Expert in Surveillance & Security utilizing Embedded Computing , Video monitoring & tracking
Expert has been involved in various aspects of the real time embedded computing market, including exposure to all types of data collection sensors including but not limited to seismic, video, acoustic, infrared, etc.. His exposure to ISR,situational ... See full profile

Texas (TX), USA

Expert in Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training ... See full profile

Alabama (AL), USA

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 Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP's
Expert, Expert's Firm Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization ... See full profile

California (CA), USA

Expert in Designing and Implementing Quality Control Stability Programs, Authoring Stability Sections
Expert has over 10 years experience in the areas of QC Stability (Drug Product and API). In addition, Expert has many years of experience in drafting QC Stability sections for the following submissions for the FDA: IND, NDA, BLA, PAS, CBE-30. See full profile

California (CA), 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 QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. See full profile

California (CA), 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 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 Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles to the ... See full profile


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 Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. See full profile

North Carolina (NC), 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 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

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 Microbiology: Bacteria, Molds/Fungi - Identification, Quality Control, Remediation, Expert Witness
Microbiology; bacteriology; mycology; microorganism identification. Expert has expertise in the identification and control of microorganisms including aspects of sterilization, disinfection, and inhibition of microbes. See full profile

Georgia (GA), 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 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 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 Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. 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

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