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CE Marking

  

graphic symbol

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United Kingdom medical device reimbursement

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European Union Authorized Representative

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United Kingdom borderline substance

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United Kingdom healthcare expense reimbursement

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In Vitro Diagnostics Directive 98/79/EC

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European market research

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European drug registration

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European marketing

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European labeling requirement

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ISO 9000 series quality system standard

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ISO 9000 quality system documentation

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foreign medical device regulation

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European standard

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ISO 9000 implementation

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medical device manufacturing

 

CE Marking Experts

The following experts are available as CE Marking consultants and CE Marking expert witnesses.  ORC 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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Join our distinguished experts for CE Marking jobs, projects and consulting opportunities.


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CE Marking Experts
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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 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 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; 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 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 Standards - Quality, Environment, H&S, Business Continuity, Information Security
Expert has implemented a number of management systems around the globe for organisations looking to improve their business through standards. Having worked for the British Standards Institution for over 10 years and with now over 10 years consultancy he is ... See full profile

England, United Kingdom

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

NJ, Israel

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 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 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

Washington (WA), 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 EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development
Expert has expertise in the design of biomedical imaging products, providing patient safety and comfort regarding ISO and FDA requirements. He is an Adjunct Professor teaching on biomedical instrumentation including cardiac, ultrasonic equipment, pressure ... See full profile

Arizona (AZ), 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 Expert for UL Certification CE Mark NFPA Hazardous Locations Elec. Codes: Get Your Certification NOW
Ul Certification. UL listed equipment and systems Underwriter's laboratory is a preeminent nationally recognized test lab. The United States. Expert will support you in obtaining UL listing and or certification for your products, by managing the whole ... See full profile

Texas (TX), USA

Expert in Electromagnetic Interference Compatibility
Expert is an iNARTE certified EMI/EMC engineer and is the owner of an independent EMI/EMC consulting company in the state of Arizona. He specializes in a variety of Electromagnetic Interference and Electromagnetic Compatibility disciplines, including: ... See full profile

Arizona (AZ), USA

Expert in Biomedical Engineering; Medical Devices
Ip Projects Catheter stabilizing device Dental Instrument Implant Seeds Intrauterine pressure catheter Vascular Catheters (3) Over 30 years experience in medical product design and development experiences in Anesthesiology, Assistive Technology, ... See full profile

Illinois (IL), USA

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