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Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…
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. Expert has directed medical device new product development projects and a product…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
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 products. Expert is proficient in total quality systems requirements…
Business Strategies
Strategic Planning; Project Planning; Performance Measurements; Balanced Scorecard: Expert has extensive experience in strategic planning, and C-level team facilitation. He has conducted strategic business planning for manufacturing, construction, publishing, distribution, and service industries. He has been involved with formulating mission…
Patran, Apex, Finite Element Analysis, Nastran, Metal Failure, Random Vibration, Strength Assessment
ABAQUS; PATRAN; NASTRAN. Expert has had three years of experience in the application of NASTRAN to space shuttle dynamics problems. He has ten years of experience in the development and technical support of PATRAN FE modeling software and interfaces between…