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Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Disposable Medical Device Manufacturing
Expert has extensive experience in the areas of disposable medical devices. Utilizing his B.S. in Plastics Engineering and 20+ years experience in medical device manufacturing, Expert assists start-ups and Fortune 500 Medical Device OEM's with their medical device manufacturing challenges.…
Statistics and Bioinformatics, Software Design, High Throughput Genomic Technologies
Experienced scientific and business leader with a background in business, personal and project development and management, focused on data analysis consulting and user centric analytical software design and development. Over 19 years of research and statistical analysis experience. In addition…
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. Whether you're…
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 product introductions. A committed professional…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Electronics, Software, Sensors, Motion Control, Wireless, and Medical Devices
Expert and his senior team have many years of experience designing embedded circuits, instruments, medical devices, and software. Expert in all types of measurements. Analog circuit design, digital circuit design, and mixed signal design, as well as measurement and control…
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. He offers full…
ISO 9001-2000/TS 16949 audits, documentation, training, assistance for certification, APQP, SPC
Expert is an ISO 9000 Lead auditor. He has been implementing developed by ISO like ISO 9000, ISO 13485, and ISO 17025 for many years. He has assisted several companies from various industries to become certified from scratch. He has…
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, Design Reviews, Verification and Validation, Material…