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.
There will be a $60 fee upon acceptance into the program
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 commercialized.
This course is designed for individuals new to the medical device and biotechnology industries or who are considering a career in Quality, Regulatory Affairs or Project Management. Professionals employed in research and development, bioengineering, quality, regulatory, law, sales and marketing who are seeking a more comprehensive picture of the medical device regulatory process will also benefit.
Practical Skill Development:
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.
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 labels. The course will also cover related aspects of associated Standards and Regulations such as Risk Management (ISO 14971), Usability (IEC 62366-1) and Software lifecycle (IEC 62304).
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 process of writing medical device submissions for regulatory agencies, both nationally and internationally and will culminate with a preparation of a sample 510(k) submission.
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.
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Candidates are encouraged to apply in the certificate program as early as possible to take advantage of program benefits.
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To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the $60 certificate fee. Although programs are open to all adult learners, UC San Diego Extension programs are designed to best serve college-prepared working professionals. Where program capacity is limited, applicants with this profile will receive preference for admission.
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There will be a $60 fee upon
acceptance into the program
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