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Medical Devices: Compliance and Audits

Auditing is a reality in the world of medical devices. There are many types of audits, including, but not limited to, first-party, internal, independent, supplier, external and agency audits. Regardless of the audit’s nature and scope, the outcome is basically the same. Typical audit outcomes require some sort of action to come into compliance with standards or regulations and make improvements to quality management systems.

A quality system audit is one of the most important Good Manufacturing Practice (GMP) requirements. Auditing medical device quality systems is like auditing quality systems everywhere, but with a distinct difference. Whereas other quality systems may look more at quality as a component of customer satisfaction, a medical device audit focuses on ensuring compliance with US Food and Drug Administration (FDA) or other regulatory agency requirements and applicable regulations with the goal of achieving patient safety and product effectiveness. Auditing any quality system will include auditing the quality system requirements (QSRs) and examining areas such as how to ensure products meet specification and whether they meet customer expectations.

FDA’s Quality System Inspectional Technique (QSIT) is designed to determine, for each subsystem, whether a firm has the appropriate controls in place and follows procedures to ensure its products conform to specifications. From these observations, FDA forms an impression of the quality system’s overall adequacy; and using QSIT, an FDA investigator will examine different products and different processes during each inspection.

Regardless of an audit’s nature and scope, corrective and preventive actions (CAPAs) typically are identified to help drive compliance to standards and continuous improvement(s). Audits often identify areas that need improvement and offer valuable insight into the proper functioning of a compliant quality system.

Course Details

 At A Glance
  • Target Audience: This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge of the audit process.
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 5 Hours
  • RAC Points: 5
  • Formats: Web and iPad
  • Cost: Member $500; Nonmember $700
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 Learning Objectives

Upon completion of this course, participants will be able to:

  • Describe FDA’s medical device compliance requirements and the requirements of other major regulatory bodies around the world.
  • Prepare and conduct an audit and an audit close-out meeting.
  • Develop the records required to document audit activities.
  • Describe auditing techniques, tips and methods employed by skilled auditors to identify underlying issues and assure compliance.
 Lesson Titles
  • Lesson 1: Medical Device Compliance
  • Lesson 2: Auditing in the US
  • Lesson 3: Auditing in the EU
  • Lesson 4: Auditing in Canada
  • Lesson 5: Auditing in the Rest of World
  • Lesson 6: Auditing Techniques and Tools
 Registration Options

This course is available for purchase as follows:

RAPS Online University