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BME59500 - Regulatory Compliance for Biomedical Devices

Summer 2015

Days/Time: Arranged / Arranged
Credit Hours: 3

Learning Objective:
Not yet finalized.

Description:
An introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of regulatory science and quality compliance and acquiring a mentored experience in preparation of key regulatory and compliance documents. Instruction and mentoring in regulatory science skills is provided by academics, consultants, or industry representatives with expertise in their fields.

Topics Covered:
History of regulation and overview of regulatory affairs; regulatory agencies and oversight; regulatory differences between devices, drugs, biologics, and combination products; current US and EU device regulations and device standards for quality control, quality assurance, and regulatory compliance; purpose and preparation of major documents in regulatory affairs.

Prerequisites:
Graduate standing.

Homework:
See Project section.

Projects:
Special project entails assembly and mock submission of an IND or NDA.

Exams:
None.

Textbooks:
None required. Class handouts to be provided.

Computer Requirements:
ProEd Minimum Computer Requirements

ProEd Minimum Requirements: view

Tuition & Fees: view

Andrew O. Brightman
Phone
765-496-3537
Email
aob@purdue.edu
Office
Purdue University
Martin C. Jischke Hall
206 S Martin Jischke Dr
West Lafayette, IN 47907-2032
Fax
765-494-1193
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