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CE Marking Experts| The following experts are available as CE Marking consultants and CE Marking expert witnesses. Intota experts are peer-recommended authorities who have been carefully selected and rigorously screened. | |
| | Definition: CE Marking -
A graphic symbol indicating that the product or device receiving it meets the requirements necessary for it to be fit for its intended purpose. It enables a company to sell the product in all 12 member countries of the European Community and in the seven member countries of the European Free Trade Association, without having to register it in each country. Synonyms: CE Mark |
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Expert Quote | | |  | | Expert in Machinery CE-Marking, Medical Device CE-Marking, CE-Marking with EU Authorized Representative Office
Iso 9000 implementation; iso 9000 auditing. Expert has expertise in implementing, documenting, and auditing procedures of medium to small companies that are pursuing ISO 9000 certification. Her organization, QNET, provides training and ... See full profile | | Minnesota (MN), 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 xDSL Splitters, Quartz Crystal and Antenna Filters, EMC, EMI, CE Marking.
Expertise on device and system modeling, EMC testing, reliability analysis (MIL-HDBK-217) and responsible at INTERISA of the electromagnetic compatibility measurements and the CE ... See full profile | | Spain | | | |  | | 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 ATEX, Area Classification, DSEAR, NEC505 Explosion Protection, Explosion Safety, IEC
Expert is the former founder and owner of an ATEX Notified Body and CE Test Facility. He has 20 years experience in Explosion Protection and associated CE Marking (LVD, Machinery, PED and EMC) and has designed or certified 1000's of products from ... See full profile | | Cheshire, United Kingdom | | | |  | | 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 Medical Devices and Diagnostics; Life Sciences Products Development, Manufacturing, Marketing
Expert has been the CEO of 6 medical device companies in three countries - 3 public, 3 private, and has been a member of the Board of Directors of seven companies. He is an expert in all areas of general and specific management of a medical device or ... See full profile | | Minnesota (MN), USA | | | |  | | Expert in Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal ... See full profile | | France | | | |  | | 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 Medical Device Manufacturing & Biocompatible Material: Orthopaedic Devices, Cardiology, Review, etc.
Expert has been actively involved in orthopaedic, cardiology and urology development projects for a number of years. All of these projects have relied upon and require biocompatible materials. As such he has developed an excellent understanding of the ... See full profile | | New Jersey (NJ), USA | | | |  | | Expert in Distribution, Retailing, International, Mergers, Consumer Products, Especially Consumer Electronics
Expert's consulting practice focuses on helping clients bring products to market and most require extensive brand planning. In addition, he taught a course in Brand and Product Management in the graduate school of business at Loyola Marymount ... See full profile | | California (CA), USA | | | |  | | Expert in Hospital tests and kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this ... See full profile | | Washington (WA), USA | | | |  | | Expert in Manufacturing, Automation, Engineering Design, Operations, Control Engineering, Food Factories
Long-standing designer of complex factory automation systems. Expert witness work has involved determining causes of program failures that have led to serious factory fires and equipment failure, as well as failure to perform to specification. See full profile | | Devon, United Kingdom | | | |  | | 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 Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO,Expert's Firm for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Ms Expert was the Medical Devices Reviewer for the ... See full profile | | India | | | |  | | 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 FDA Regulations for Medical Devices, QSR, Risk Management, Medical Device Design
Expert (MSEE) has designed medical devices and equipment for over 20 years. He helped companies develop medical devices, obtain 510(k) clearances, and comply with QSR (cGMP) for over 15 years. Expert has expertise in Risk Management per ISO ... See full profile | | California (CA), USA | | | |  | | Expert in Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years' work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, ... See full profile | | Ontario, Canada | | | |  | | 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 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 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 Biomedical Device Engineering
Biomedical product development; medical device product development; new product development. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. See full profile | | South Africa | | | |  | | Expert in Acoustics and Noise Control
Expert is the owner and principal consultant of Expert's Firm, a consulting firm specializing in acoustics and noise control. He is a registered professional engineer, and he has been involved with acoustics and noise control ... See full profile | | Ohio (OH), USA | | | |  | | Expert in Industrial and High Technology Equipment 3rd Party Certification/Design CE S2 NFPA Electrical Codes
Expert chaired SEMI EHS standards writting committee for ten years. Expert has reviewed and evaluated for electrical and electronic safety. Electrical safety is a design based practice. Expert provides the knowledge base to speed design and completion while ... See full profile | | Texas (TX), 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 | | |  | | >> Next 25 Experts
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