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UNDERSTANDING THE MEDICAL PRODUCT DEVELOPMENT PROCESS: CONTINUING PROFESSIONAL DEVELOPMENT FOR LIFE SCIENCE PROFESSIONALS

机译:了解医疗产品开发过程:持续专业发展的生命科学专业人士

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Navigating the medical product development maze from concept to market can result in a challenging experience. The life science industry is a highly regulated industry and depending on the medical product and classification (device, pharmaceutical, or biologic) the approval process can be complex and lengthy. Unlike high-tech products such as consumer electronics which may have a relatively short time-to-market cycle, medical products can take anywhere from 3 to 7 years before they make it to the market. Modern technology has made many inroads in the advancement of medical technology and engineers and scientists are playing a key role. As students make the transition to becoming professionals and professionals seek to enhance their careers, continued education and skills enhancement is taking center stage. This paper describes the development of a continuing education certificate program in medical product development for both professional development and workforce development. Various disciplines may be involved throughout the development cycle from marketing to engineering to regulatory affairs. Possessing a thorough understanding of medical product design and manufacturing increases the level of expertise needed to enhance the safety and quality of medical products. A common development cycle for medical products is presented with explanations of the various phases within the product development cycle. The Medical Product Development Certificate program has been designed to provide core knowledge of the medical product development process. Through evaluated learning and competency-based courses, students increase their knowledge of clinical and regulatory compliance, good manufacturing practices, and quality assurance.
机译:从概念到市场导航医疗产品开发迷宫可能会导致具有挑战性的经历。生命科学行业是一个受规范的行业,具体取决于医疗产品和分类(设备,制药或生物学),审批过程可以复杂和冗长。与可能具有相对较短的市场周期的消费电子产品等高科技产品不同,医疗产品可以在他们到市场之前的3到7年。现代技术在医疗技术和工程师和科学家的进步方面取得了许多进球,并在发挥关键作用。随着学生转型为成为专业人士和专业人士寻求提升他们的职业生涯,持续的教育和技能增强正在接受中心阶段。本文介绍了专业发展和劳动力发展的医疗产品开发中继续教育证书计划的发展。在整个发展周期中可能涉及各种学科,从营销到工程到监管事务。彻底了解医疗产品设计和制造业增加了提高医疗产品安全和质量所需的专业知识。医疗产品的常见开发周期具有产品开发周期内各阶段的解释。医疗产品开发证书计划旨在提供医疗产品开发过程的核心知识。通过评估的学习和基于能力的课程,学生提高了对临床和监管合规性,良好的制造实践和质量保证的了解。

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