Courses
Medical Device Development
This is a basic online course about Medical Device Development for new professionals or those just entering the field. The processes used in companies to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. The course is 100% online and modeled after the “Medical Device Development” class taught at the New Jersey Institute of Technology since 2009.
Advanced Medical Device Development
Material in this course picks up from the point of “design freeze” and discusses the events occurring from then on through obsolescence. Aspects of managing devices covered in this course include: Manufacturing process development and validation, Regulatory systems outside the United States, Clinical trial practices, and Product Management. The course is 100% online and modeled after the “Advanced Medical Device Development” class taught at the New Jersey Institute of Technology since 2013.
Project Management for Medical Devices
This is a basic online course about how to manage medical device projects for new professionals or those just entering the field. Courses in Project Management (PM) abound both in the classroom and online. However, nearly all currently available courses focus either on generic PM or specific industries such as construction and software development. There is a decided lack of PM courses that address medical device development (MDD). Enter this course.
Clinical Trials for Medical Devices
This course takes the painfully dry regulations and methods used for clinical trials on medical devices and distills them nicely into a clean overview over the course of an hour. Students will learn about Good Clinical Practices (GCP’s) and associated regulations, 21 CFR Parts 50, 56, and 812 and the ICH guidelines. Material from this course is included in the Advanced Medical Device Development course.
European Medical Device Regulatory Basics
This is a basic online course for beginners that want to start learning about European Medical Device Regulatory Basics. The material breaks down the essential governmental structure of the EU and how this relates to the three different directives for medical devices: Medical Device Directive 93/42/EEC, In Vitro Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. Once establishing this framework, the course covers the different regulatory organizations and documents needed to gain a CE Mark allowing a device to be sold in the EU. The course is 100% online and modeled after the “Medical Device Development” class taught at the New Jersey Institute of Technology since 2009.