The Quality System Regulations (QSRs), established in 1996 by the US Food and Drug Administration (FDA), provide direction to medical device manufacturers in the manufacturing, packaging and distribution of finished medical products. The QSRs were created to ensure that safe and effective device products are used in the marketplace. Establishing a quality system ensures that a medical device manufacturer conforms to the requirements of the QSRs. FDA then performs periodic inspections of medical device manufacturers to assure their quality systems are meeting the expectations of the QSRs. A company must document its activities to provide objective evidence that it is conforming to the requirements of the QSRs.
This course provides a systematic approach to the QSRs, examining key subparts. It covers the historical background, gives an overview of the regulations and addresses how the QSRs apply to medical device manufacturers. The course is intended to facilitate an understanding of the intent and expectations of FDA, how to implement a quality system, and how the QSRs can be applied to a medical device manufacturer.
Learning Objectives
Upon completion of this course, participants should be able to:
- Discuss the QSR in terms of application and requirements of a medical device company for designing, manufacturing, packaging and distributing medical devices
- Cite the requirements of a quality management system that a medical device manufacturer must establish and implement
- Apply the requirements mandated by FDA for medical device manufacturers to the different processes within the organization
- Explain the basics of implementing a quality system and interpreting the QSRs for practical application for the organization
- Identify the different procedures, work processes and quality records that must be generated to support an inspection by FDA
Target Audience
This course is designed for quality assurance, regulatory, manufacturing and marketing personnel; individuals who are new to medical device companies and executive management.