The OrthoWorx Center for Excellence in Orthopaedics at Grace College proudly offers the nation’s only graduate program designed specifically by and for orthopaedic regulatory and clinical affairs professionals. Students can earn a M.S. in Orthopaedic Regulatory and Clinical Affairs in this accelerated four semester program.
As the “Orthopaedic Capital of the World,” Warsaw, Indiana contains one of the most concentrated clusters of economic activity in the orthopaedic industry than anywhere else in the United States. Today, the Warsaw region is headquarters to nearly one-third of the $38 billion global orthopaedic industry, which represents one of the most significant components of Indiana’s economy.
Grace College and OrthoWorx, with support from the Lilly Endowment, have partnered to provide this graduate program, which is targeted to professionals who desire a thorough knowledge of the laws and regulations mandated by the federal government, especially the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing and commercialization of orthopaedic products. This degree also aligns with RAPS the leader in the regulation of healthcare and related products, including establishing standards in the regulatory professions.
Prospective students could include:
Candidates must have completed a bachelor’s degree from an accredited institution. In some cases, candidates who can successfully complete a bachelor’s degree while enrolled in the ORCA program may also be considered.
All courses are 3 credit hours and will be taught in a 5-week format with class sessions being held one evening per week for 4 hours. For the 2017-2018 school year, the weekly class will meet every Tuesday evening.
Courses in this major:
This course will expose students to the foundational information which will be expanded upon in later courses. Students will become familiar with important aspects of regulatory science, including anatomy, terminology, regulatory bodies, medical device categories, and the industry in general.
In this course, students will begin their study of the regulatory lifecycle for medical devices, covering predicate/comparator devices, document controls, standards, intellectual property and patent issues, and sample products.
This course will give students a broad understanding of manufacturer and vendor requirements set forth by regulatory bodies, including change assessment and international registration impact assessment, and how they affect the medical device lifecycle.
The combination of these two courses will help students gain an understanding of design controls, risk management, and validation processes, as well as clinical trial design and management techniques, in order to successfully bring a medical device to market.
These courses will provide students with an in depth understanding of the FDA and U.S. regulatory requirements for medical devices, including classification of devices, pathways to market, submissions, registrations, FDA inspections, etc.
Building upon knowledge from the U.S. compliance courses, this course will expose students to the similarities and differences between U.S. and E.U. regulations and requirements in order to increase accuracy and efficiency of submissions.
This course will provide students with a cursory overview of medical device regulations on a global scale, highlighting major countries and regions such as Canada, China, Japan, Russia, Australia, Latin America, and Asia/Pacific.
Topics covered in this course will provide an in depth understanding of standards and requirements for labeling and advertising medical devices in the U.S. and abroad, as well as reimbursement and Health Care Professional (HCP) interactions.
Students will, in this course, develop knowledge about the requirements for post-market surveillance and reporting requirements, as well as skills to assess various outcomes in the post-market sector, such as recalls, design enhancements, CAPAs, audits, and inspections.
The capstone experience will require students to utilize the knowledge gained from each class about the industry and regulatory lifecycle to create a mock submission for a medical device.