Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use.
This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
This two day course is designed for Medical Device professionals involved in clinical trials. It is primarily designed to benefit the following disciplines and personnel:
Introduction to Clinical Trials
Premarket vs. Post Market Clinical Trials
How Claims for Medical Use Impact Trial Design
Protection of Human Subjects
Institutional Review Boards (IRB)/Ethics Committees (EC)
US and EU Premarket Regulatory Requirements
Changes during the Conduct of the Trial
Regulatory Reporting and Record Keeping Requirements
Design of Clinical Study Protocols
Preparation of Clinical Study Report
By the end of the course, participants will be able to:
"Best instructor to date, very knowledgeable with excellent communication and educational skills." Marie D., Manager, Regulatory Compliance, American College of Radiology
"This course director has an extensive knowledge base and experience in regulatory affairs, clinical research and compliance, which is communicated very effectively to course attendees. This has enabled me and inspired me to pay greater attention to detail in the course of my clinical research activities as a multi-center trial P.I. than ever before. Thank you!." Dr. Alexander S., Colonel, Walter Reed Army Medical Center
"The course was fantastic. It was the best medical device course I have attended." David H., Clinical Trials Coordinator, Cook Biotech Inc.
"The Course Director was very knowledgeable and accommodated all of our questions and was also available during breaks and after class for questions." Denese S., Clinical Research Associate, Covidien
"The course was very informative. The Course Director was well informed and conveyed a wealth of experience in the practical application of course material." Alastair R., Doctor, D3 Technologies
"This course was very beneficial and went into more detail that I expected. The real life examples were great. The instructor did a nice job of keeping the class engaged and attentive. This was a useful course and I would recommend it." Jennie R., Clinical Research Associate, Ocular Therapeutics
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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