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Regulatory Affairs for Medical Devices

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Medical device development is a dynamic area for professionals considering a career in regulatory affairs and can be as simple as a Band-Aid or as highly complex as lifesaving robotic equipment. Medical devices are increasing in complexity and becoming ubiquitous in the medical field. More recently, the convergence of medical devices with other industries has propelled growth and required more professionals to learn regulations. New products built from a combination of information technology and software enabled medical devices have expanded the need for those involved to learn regulatory requirements, including engineers and other technical associates. Additionally, a convergence of medical devices and drugs brings new treatment opportunities to healthcare, including drug coated stents used for cardiovascular procedures. The advent of such combination products make it necessary for therapeutics professionals involved in regulatory affairs to also become knowledgeable of regulations that apply to such devices.

The Regulatory Affairs for Medical Devices certificate provides professionals with the essential knowledge to work in this highly regulated environment and the process needed to develop medical devices from concept to commercialization.

Format

 

Online

*Options may vary by quarter.

Est. Cost

 

$3,465*

*not including textbooks

Duration

 

9 -15 Months*

*Varies by student and courses taken per quarter.

 

Certificate Benefits
  • Program designed to be completed in only one year
  • Complete all courses online in the convenience of your own home or office
  • Hands-on comprehensive training designed to immerse you in the skills needed to successfully get started or advance your career
  • Courses taught by leading industry practitioners
Learning Objectives
  • Understand the overall product development life cycle
  • Understand how to work proactively with the FDA
  • Understand how a quality management system works within a medical device company
  • Understand the overall design control process and risk analysis
  • How to prepare a 501(k) submission to the FDA
  • How to perform post market surveillance to insure safety
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There will be a $95 fee upon acceptance into the program

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There will be a $95 fee upon
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about Regulatory Affairs for Medical Devices