Regulatory Affairs for Medical Devices

The healthcare industry is dynamic and full of exponential growth. In this innovative and regulated industry, it is essential for medical device professionals to understand the business, science and regulations in developing a medical device from concept to commercialization. In this course students will develop an understanding of the regulatory affairs environment, how to navigate and work with the FDA; and the steps and timetable to develop and commercially market medical devices in the United States. It will also highlight post market compliance issues once a device has been...

The cornerstone in the efficient manufacturing of a medical device is the implementation of a quality management system. Medical Device companies are required to develop a QMS that conforms to the regulations imposed by the FDA and ISO 13485 to ensure the safety of a medical device on the market. This course will provide an in depth look into the FDA Quality System Regulation (21CFR820), and International Standard ISO 13485 for Quality Management Systems. You will also learn the related aspects of Risk Management and Medical Device Reporting. Topics include: Design, Document , Production...

Developing a new medical device for commercialization is a complex process. The FDA has guidelines that provide a framework for designing and manufacturing medical devices. This course will provide a detailed and practical overview of the design control process for medical device design and development. The course will cover design control under the FDA Quality System Regulation (21CFR820.30) and international Standard ISO 13485 for Quality Management Systems, in addition to the practical application in the design and development of electronic hardware, software, mechanical elements and...

Are you ready to enter your medical device into the commercial marketplace? This course covers the specifics of regulatory submissions made to the FDA for the purpose of placing a medical device on the commercial market. Submissions covered will include: pre-submissions (pre-IDE and pre-510(k)); IDE; PMA; and 510(k). Additionally international submissions for CE mark will also be introduced. This workshop style course will offer students an opportunity to practice understanding and gathering the complex scientific information required in various regulatory submissions. You will examine the...

Once a medical device is commercialized, FDA requirements mandate that a company must perform Post Market Surveillance (PMS) to ensure public safety and efficacy. This course will provide a detailed training on a variety of Post Market Topics and will introduce professionals to the many typical situations they may be responsible for during the weeks, months and years after commercialization of a product. Learning will be done by studying regulations, investigating the history of other companies (particularly failures), and sharing experiences within the class. Topics Include: * Complaint...

Learn Companion Diagnostics (CDx) for Precision Medicine Online Dive into the cutting-edge world of precision medicine with our advanced course on Companion Diagnostics (CDx). This dynamic program offers a deep dive into the development pathways, regulatory landscapes, and the intricate business relationships between pharmaceutical and diagnostic companies. Through an in-depth exploration of FDA regulatory frameworks, real-world case studies, and a critical analysis of recent industry collaborations and market trends, students will gain a comprehensive understanding of how CDx is...

In Vitro Diagnostics Product Development As biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the skills required to be effective in a biological product development environment will increase. In this course, learn the requirements for moving an IVD product from concept to regulatory approval and market launch. Topics include planning for success by setting product requirements & specifications to meet customer needs, critical path management, resource planning, principles of assay development, instrumentation, role and...